HOSPITAL/MEDICAL/INFECTIOUS 

WASTE INCINERATORS: 

Summary of Requirements for Revised or New 

Section 111(d)/129 State Plans Following Amendments 

to the Emission Guidelines 
ii 
EPA-453/B-10-001 

October 2010 

Hospital/Medical/Infectious Waste Incinerators: 

Summary of Requirements for Revised or New Section 111(d)/129 State Plans Following 

Amendments to the Emission Guidelines 

By: 

RTI International 

Research Triangle Park, North Carolina 

Prepared for: 

Office of Air Quality Planning and Standards 

Sector Policies and Programs Division 

Contract No. EP-D-06-118 

Work Assignment No. 4-23 

U.S. Environmental Protection Agency 

Office of Air Quality Planning and Standards 

Sector Policies and Programs Division 

Natural Resources and Commerce Group 

Research Triangle Park, NC 

iii 
Disclaimer

This document does not establish any new requirements and is not binding or 

enforceable. It does not constitute final agency action under Clean Air Act section 307(b)(1), 42 

U.S.C. 7607(b)(1). Rather, it summarizes existing regulations and provides guidance to States 

pertaining to State Plan development under Section 129 of the Clean Air Act as amended in 

1990. 

iv 
Executive Summary

Air pollution emissions from the incineration of hospital waste and medical/infectious 

waste are regulated by federal rules promulgated to implement the Clean Air Act (CAA) as 

amended in 1990. This guidance document addresses requirements established by the 

regulations that have been developed and amended for hospital/medical/infectious waste 

incinerator(s) (HMIWI) under sections 111 and 129 of the CAA. Section 111 of the CAA, 42 

U.S.C. 7411, addresses Standards of Performance for Stationary Sources. Section 129, 42 

U.S.C. 7429, addresses Solid Waste Combustion. The original HMIWI regulations were 

promulgated by EPA on September 15, 1997. Amendments to the regulations were promulgated 

on October 6, 2009. 

Federal rules under the CAA promulgated in the Code of Federal Regulations (CFR) that 

affect the combustion of hospital waste and medical/infectious waste include: 

1. Emission Guidelines and Compliance Times for Hospital/Medical/Infectious 

Waste Incinerators [40 CFR Part 60, subpart Ce, as amended October 6, 2009] 

(The amended Emission Guidelines [EG] apply to all HMIWI that commenced 

construction on or before June 20, 1996; the amended EG also apply to those 

HMIWI that commenced construction after June 20, 1996 but no later than 

December 1, 2008, except where the emission limits in the original 1997 new 

source performance standards [NSPS] are more stringent); 

2. Rules Governing the Adoption and Submittal of State Plans for Designated 

Facilities [40 CFR Part 60, subpart B]; 

3. Standards of Performance for Hospital/Medical/Infectious Waste Incinerators for 

Which Construction is Commenced After June 20, 1996 [40 CFR Part 60, 

subpart Ec, as amended October 6, 2009] (The original NSPS promulgated in 

1997 apply to those HMIWI that commenced construction after June 20, 1996 but 

no later than December 1, 2008, except where the emission limits in the amended 

EG are more stringent; the amended NSPS apply to those HMIWI that 

commenced construction after December 1, 2008); 

4. Federal Plan Requirements for Hospital/Medical/Infectious Waste Incinerators 

Constructed On or Before June 20, 1996 [40 CFR Part 62, subpart HHH] (The 

Federal Plan Requirements apply to those HMIWI that commenced construction 

on or before June 20, 1996; the Federal Plan Requirements have not yet been 

amended to incorporate the provisions in the amended EG); and 

v 
5. Approval and Promulgation of State Plans for Designated Facilities and 

Pollutants; General Provisions [40 CFR Part 62, subpart A] (These General 

Provisions are applicable to all section 111(d)/129 plans and revisions). 

Unlike the subpart Ec NSPS, which apply directly to new sources, states develop a State 

Plan in order to compel existing sources to meet the EG. Together, subpart B and subpart Ce 

specify the State Plan content and the general rules for adopting and submitting State Plans. 

State Plans have already been developed to implement the EG adopted on September 15, 1997, 

and states need to revise existing or develop new State Plans to implement the amended EG 

adopted on October 6, 2009. Working with EPA Regional Offices and states, EPA’s Office of 

Air Quality Planning and Standards has produced this guidance document to assist states in 

ensuring that their revised or new State Plans are complete and meet all the requirements of 

subpart B and subpart Ce, as amended on October 6, 2009. 

This document draws together relevant information from the federal regulations that 

affect hospital and medical/infectious waste incineration to give state regulatory agencies the 

information they need to revise or develop State Plans. Section 1 of this document provides an 

overview of regulatory and State Plan requirements; section 2 presents information on the 

timeline and responsibilities for revising/developing and submitting these State Plans; and 

section 3 discusses the required elements of a State Plan. The appendices to this document 

contain reference and explanatory materials, including: 

1. Key elements of an acceptable State Plan; 

2. A Fact Sheet on the amended EG; 

3. Clarifications of the applicability of the amended EG; 

4. An implementation timeline; 

5. Contacts for further information; 

6. Emission factors for calculating HMIWI air pollutant emissions; 

7. A copy of CAA section 111(d); 

8. A copy of CAA section 129; 

9. A copy of 40 CFR Part 60, subpart B (rules governing adoption/submittal of State 

Plans); 

10. A copy of 40 CFR Part 62, subpart A (General Provisions regarding approval/ 

promulgation of State Plans); 

11. Copies of 40 CFR Part 60, subpart Ce (amended EG) and subpart Ec (amended 

NSPS); 

12. A copy of the Federal Register (FR) notice for the amended EG; and 

13. The latest (2010) inventory of HMIWI. 

vi 
An appendix that was included in the original version of this document, published in 

November 1997 (Answers to Questions about the Emission Guidelines and State Plan Process) 

will be updated and provided as a separate document. 

The CAA directs state regulatory agencies to implement the EG according to a State Plan 

developed under sections 111(d) and 129 of the CAA, and to submit the State Plan to EPA 

within 1 year after EPA's promulgation of the EG (i.e., by October 6, 2010 for the amended EG). 

To be approved by EPA, the State Plans need to contain specific information and the legal 

mechanisms necessary to implement the EG. The minimum requirements set forth in CAA 

section 129 and in 40 CFR Part 60, subparts B and Ce are listed below. 

1. A demonstration of the state's legal authority to carry out the section 111(d)/129 

State Plan and identification of enforceable mechanisms, including: 

- a list in the enforcement section of the State Plan indicating the 

consequences for sources not in compliance and the authority under which 

a state can shut down/close a source; 

- a reference to section 129(f)(3) (“PROHIBITION“), which prohibits a 

plant from operating if it does not comply with the standard; and 

- adequate authority to enforce the recordkeeping and notification 

requirements for co-fired combustors and incinerators burning only 

pathological, low-level radioactive, and chemotherapeutic waste. 

[CAA section 129(f)(3) and 40 CFR 60.26 and 60.32e(b) and (c)] 

2. An inventory of sources in the state affected by the EG, including to the best of 

the state’s knowledge, HMIWI that have shut down and are capable of restarting, 

and including: 

- a statement preceding the inventory which says that sources subject to the 

standard “include but are not limited to” the inventory in the State Plan, 

and 

- an additional statement that says, “should another source be discovered 

subsequent to this notice, there will be no need to reopen the State Plan.” 

[40 CFR 60.25(a)] 

3. An inventory of emissions from HMIWI operating in the state. [40 CFR 60.25(a) 

and (c)] 

4. Emission limits for HMIWI that are at least as protective as those in the EG. 

[CAA section 129(b)(2) and 40 CFR 60.24(a)-(c) and 60.33e] 

5. Testing and monitoring requirements at least as protective as those in the EG. 

[CAA section 129(b)(2) and 40 CFR 60.24(b)(2), 60.25(b), and 60.37e] 

6. Reporting and recordkeeping requirements at least as protective as those in the 

EG. [CAA section 129(b)(2) and 40 CFR 60.25(b)(1) and 60.38e] 

vii 
7. Operator training and qualification requirements at least as protective as those in 

the EG. [CAA section 129(b)(2) and (d) and 40 CFR 60.34e] 

8. Inspection requirements at least as protective as those in the EG. [CAA section 

129(b)(2) and 40 CFR 60.25(b)(2), and 60.36e] 

9. Waste management plan requirements at least as protective as those in the EG. 

[CAA section 129(b)(2) and 40 CFR 60.35e] 

10. Compliance schedules (including increments of progress for compliance 

schedules which extend beyond 1 year after State Plan approval). [40 CFR 

60.24(a) and (e)(1) and 60.39e] 

11. An expeditious final compliance date not later than 3 years after approval of the 

revised or new State Plan or October 6, 2014, whichever is earlier.1

 [CAA section 

129(b)(2) and (f)(2) and 40 CFR 60.39e(c)] 

12. A record of public hearing(s) on the State Plan. [40 CFR 60.23(f)(1) and (2)] 

13. Provision for state progress reports to EPA. [40 CFR 60.25(e) and (f)] 

Prior to submittal to EPA, EPA’s regulations direct the state to make available to the 

public the State Plan and provide an opportunity for public comment. [40 CFR 60.23(c)] The 

deadline for the state to submit the final revised or new State Plan to EPA is October 6, 2010. 

[CAA section 129(b)(2) and 40 CFR 60.39e(a)(2)] EPA then has 180 days (6 months) to 

approve or disapprove the State Plan. [CAA section 129(b)(2)] State Plan approval or 

disapproval will be published in the FR. If a State Plan is disapproved, EPA will state the 

reasons for disapproval in the FR and give the state an opportunity to respond to EPA's concerns 

and submit a revised State Plan. [CAA section 129(b)(2)] Pursuant to section 129(b)(3), a 

Federal Plan would need to be in place by October 6, 2011 for each state that does not have an 

approved revised or new State Plan. [CAA section 129(b)(3) and 40 CFR 60.39e(f)] 

Based on EPA’s latest (2010) inventory of HMIWI subject to the EG (see Appendix M), 

54 HMIWI are subject to the amended EG, with a total combustion capacity of approximately 

224,000 tons per year. (Note: EPA estimated 57 HMIWI were operating when the October 6, 

2009 EG were being developed, and 3 of those HMIWI have since shut down.) According to the 

 1

Final compliance beyond 1 year after State Plan approval is possible only if the State 

Plan contains increments of progress (see section 10). [40 CFR 60.24(e) and 60.39e(c)] 

viii 
2010 inventory, 96 percent of the HMIWI (which represent 99.9 percent of the U.S. HMIWI 

combustion capacity) employ some kind of add-on air pollution control device (APCD). An 

additional 4 percent of the HMIWI population (which constitute approximately 0.1 percent of the 

U.S. HMIWI combustion capacity) are believed to have good combustion.2

 An estimated 87 

percent of the HMIWI (which represent 88 percent of the U.S. HMIWI combustion capacity) 

will require retrofit of an additional APCD to meet the amended EG. The table below presents 

the number of currently operating HMIWI by state. 

Table 1. Number of Hospital/Medical/Infectious 

Waste Incinerators by State

EPA Region State Number of HMIWIa

I Connecticut 1 

II New Jersey 1 

III Maryland 7 

Pennsylvania 6 

West Virginia 2 

IV Florida 10 

Georgia 1 

North Carolina 4 

Tennessee 1 

V Minnesota 1 

Illinois 3 

Indiana 3 

Ohio 4 

VI Texas 3 

VII Kansas 1 

VIII Montana 1 

North Dakota 1 

Utah 1 

Wyoming 1 

IX Hawaii 1 

X Alaska 1 

 2

To the extent that good combustion is defined, it means 2-second residence time in the 

secondary chamber at 1800ΕF. However, the Emission Guidelines do not require 2-second 

residence time and 1800ΕF. [docket no. A-91-61, document no. II-A-112, page 31] 

ix 
x 

EPA Region State Number of HMIWIa

Total 54 

a

 The inventory of HMIWI is based on data gathered from contacts with EPA 

Regions, states, and HMIWI facilities and from review of existing HMIWI 

inventories, title V permits, emission test reports, and HMIWI facility websites. 

The figure below shows the location of the HMIWI currently in operation (2010) (see 

Appendix M), compared to those HMIWI in operation in 1995—the date of the last inventory 

prepared prior to the 1997 HMIWI regulations (see docket no. A-91-61, document no. IV-B-45).
Figure 1. Inventory of Existing Hospital/Medical/Infectious Waste Incinerators (1995 a

xi 
xii 
xiii 

Table of Contents

Page 

Disclaimer ...................................................................................................................................... iv

Executive Summary .........................................................................................................................v

Table of Contents ......................................................................................................................... xiii

1.0 Introduction ........................................................................................................................... 1-1

1.1 Organization of this Document .............................................................................. 1-2

1.2 Clean Air Act Requirements .................................................................................. 1-2

1.3 Emission Guidelines .............................................................................................. 1-4

1.4 Emission Guideline Subcategories ........................................................................ 1-5

1.5 Requirements for State Plans ................................................................................. 1-6

1.6 Requirements for Negative Declarations ............................................................. 1-10

1.7 Relationship Between the Section 111(d)/129 State Plan and SIP ...................... 1-10

2.0 Schedule and Responsibilities............................................................................................... 2-1

2.1 State Plan Schedule ................................................................................................ 2-1

2.2 Responsibilities ...................................................................................................... 2-4

2.2.1 EPA Responsibilities ...................................................................................... 2-4

2.2.2 State Responsibilities ..................................................................................... 2-5

2.2.3 Source Responsibilities .................................................................................. 2-6

3.0 Required Elements of an Acceptable State Plan ................................................................... 3-1

3.1 Demonstration of Legal Authority ......................................................................... 3-1

3.2 Enforceable Mechanisms ....................................................................................... 3-3

3.3 Inventory ................................................................................................................ 3-4

3.3.1 Source Inventory ............................................................................................ 3-4

3.3.2 Emission Inventory ........................................................................................ 3-5

3.4 Compliance with Emission Limits ......................................................................... 3-7

3.5 Determining HMIWI Compliance Status .............................................................. 3-9

3.5.1 Testing Requirements ................................................................................... 3-10

3.5.2 Monitoring Requirements ............................................................................ 3-10

3.5.3 Reporting and Recordkeeping Requirements ............................................... 3-11

3.5.4 Operator Training and Qualification Requirements ..................................... 3-11

3.5.5 Waste Management Plan Requirements ....................................................... 3-12

3.5.6 Inspection Requirements .............................................................................. 3-12

3.6 Compliance Schedules ......................................................................................... 3-13

3.6.1 Retrofit Required .......................................................................................... 3-14

3.6.2 Retrofit Schedules for HMIWI ..................................................................... 3-15

3.6.3 Increments of Progress ................................................................................. 3-15

3.6.4 HMIWI Shutdowns ...................................................................................... 3-18

3.7 Public Hearings .................................................................................................... 3-20

3.8 State Progress Reports to EPA ............................................................................. 3-21

4.0 Requirements for Co-fired Combustors and Incinerators Burning Only Pathological, 

Low-level Radioactive, and Chemotherapeutic Waste ......................................................... 4-1

5.0 Title V Requirements for HMIWI ........................................................................................ 5-1

5.1 Existing HMIWI .................................................................................................... 5-1

5.2 Exempt Units ......................................................................................................... 5-2
Appendices

A Key Elements of an Acceptable Section 111(d)/129 State Plan for HMIWI 

B Fact Sheet for Amended Emission Guidelines and NSPS (40 CFR Part 60 

Subparts Ce and Ec) 

C Applicability of the HMIWI Emission Guidelines 

D HMIWI Implementation Timeline 

E EPA Regional and State/Local Agency Contacts 

F HMIWI Emission Factors 

G Clean Air Act Section 111(d) 

H Clean Air Act Section 129 

I 40 CFR Part 60 Subpart B 

J 40 CFR Part 62 Subpart A 

K 40 CFR Part 60 Subparts Ce (EG) and Ec (NSPS) 

L Federal Register Notice for Amended Emission Guidelines and NSPS (40 CFR 

Part 60 Subparts Ce and Ec) 

M 2010 HMIWI Inventory 

List of Figures

Page

Figure 1. Inventory of Existing Hospital/Medical/Infectious Waste Incinerators 

(1995 and 2010). ........................................................................................... xi 

Figure 2-1. HMIWI Implementation Timeline ................................................................ 2-2 

List of Tables

Page

Table 1. Number of Hospital/Medical/Infectious Waste Incinerators by State .......... ix 

Table 1-1. Appendices to This Document ...................................................................... 1-3 

Table 1-2. Relationship Between Section 111(d), Section 129, and Subpart B ............. 1-4 

Table 1-3. Outline of the Emission Guidelines for HMIWI ........................................... 1-5 

Table 1-4. Regulations for Adopting and Submitting State Plans .................................. 1-9 

Table 2-1. Sample State Schedule for Section 111(d)/129 State Plans .......................... 2-3 

Table 3-1. Summary of Requirements for Section 111(d)/129 State Plans .................... 3-2 

Table 3-2. Schedule for HMIWI Compliance with the HMIWI Emission Guidelines .. 3-13 

   

xiv 
xv 

List of Acronyms and Abbreviations

AFS Air Facility System 

APCD Air Pollution Control Device 

CAA Clean Air Act 

cc Carbon Copy 

Cd Cadmium 

CEMS Continuous Emission Monitoring System 

CFR Code of Federal Regulations 

CISWI Commercial and Industrial Solid Waste Incinerators 

CO Carbon Monoxide 

DIFF Dry Injection Fabric Filter 

Dioxins/furans Tetra- through octa- chlorinated dibenzo-p-dioxins and dibenzofurans 

EPA U.S. Environmental Protection Agency 

FR Federal Register

HMIWI Hospital/Medical/Infectious Waste Incinerator(s) 

HCl Hydrogen Chloride 

Hg Mercury 

lb/hr Pounds per hour 

MSA Metropolitan Statistical Area 

MWC Municipal Waste Combustor 

NAAQS National Ambient Air Quality Standards 

NEDS National Emissions Data System 

NESHAP National Emission Standards for Hazardous Air Pollutants 

NO2 Nitrogen Dioxide 

NOx Nitrogen Oxides 

NSPS New Source Performance Standard 

OSWI Other Solid Waste Incinerators 

Pb Lead 

PM Particulate Matter 

PM10 PM with an Aerodynamic Diameter at or below 10 μm 

QA/QC Quality Assurance/Quality Control 

SIP State Implementation Plan 

SMSA Standard Metropolitan Statistical Area, as referenced in OMB Bulletin No. 

93-17, dated June 30, 1993 

SNCR Selective Noncatalytic Reduction 

SO2 Sulfur Dioxide 

TCDD Tetrachlorodibenzo-p-dioxin 

TEQ 2,3,7,8-TCDD Toxic Equivalent
xvi 
1.0  Introduction

The purpose of this document is to assist state air regulatory agencies in developing 

revised or new State Plans which will implement the amended regulations controlling air 

pollutant emissions from hospital/medical/infectious waste incinerator(s) (HMIWI). Under the 

Clean Air Act (CAA) as amended in 1990, the United States Environmental Protection Agency 

(EPA) is required to develop regulations to control air pollutant emissions from HMIWI. 

Emissions from new HMIWI are addressed by standards of performance for new sources (New 

Source Performance Standards [NSPS]), and emissions from existing HMIWI are addressed by 

guidelines for existing sources (Emission Guidelines [EG]). EPA originally promulgated the 

NSPS (subpart Ec) and EG (subpart Ce) for HMIWI on September 15, 1997. In a response to a 

suit filed by the Sierra Club and the Natural Resources Defense Council, 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 

states developed State Plans to implement the original EG for existing sources. For any states 

without an acceptable State Plan, EPA developed a Federal Plan (published in the FR on August 

15, 2000 [65 FR 49868]) to implement the original EG. The original EG were fully implemented 

as of September 15, 2002. 

On February 6, 2007, EPA published a proposed response to the Court’s remand and 

solicited public comments. Following recent court decisions and receipt of public comments on 

the proposal, EPA re-assessed its response to the remand, and on December 1, 2008 published 

another proposed response and again solicited public comments. On October 6, 2009, EPA 

published its final response to the Court’s remand and also satisfied the CAA section 129(a)(5) 

requirement to conduct a review of the standards every 5 years. EPA’s response to the remand 

and section 129(a)(5) requirement included substantial revisions to the NSPS and EG. States are 

to revise, amend, or develop State Plans to implement the amended EG for existing sources and 

submit these revised or new State Plans to EPA by October 6, 2010. On May 14, 2010 at FR 75 

FR 27249, EPA published proposed amendments to the NSPS, correcting the nitrogen oxides 

(NOx) and sulfur dioxide (SO2) emissions limits for new large HMIWI, as well as errors in 

cross-references in the NSPS reporting and recordkeeping provisions for new HMIWI. These 

amendments are intended to match the final NOX and SO2 EG limits, which reflect EPA’s intent 

1-1 
in the October 6, 2009 final rule; however, these revisions do not impact States’ implementation 

of the EG. At the time of publication of this document, EPA’s final action promulgating the 

amendments is pending the Administrator’s signature. 

 This document provides state agencies information on the content these State Plans need 

to include in order to obtain EPA approval, under EPA’s regulations. This document is an 

update to the November 1997 guidance document entitled “Hospital/Medical/Infectious Waste 

Incinerator Emission Guidelines: Summary of the Requirements for Section 111(d)/129 State 

Plans” (EPA-456/R-97-007). 

1.1 Organization of this Document

This document discusses the information on the relevant parts of the various regulations 

that affect existing HMIWI constructed on or before December 1, 2008. These regulations were 

developed under section 111(d) and section 129 of the CAA. The regulations are codified in 

title 40 of the Code of Federal Regulations (CFR) Parts 60 and 62. The rules include 

(1) Adoption and Submittal of State Plans for Designated Facilities (40 CFR Part 60, subpart B); 

(2) the EG for existing HMIWI (40 CFR Part 60, subpart Ce), as amended October 6, 2009; and 

(3) Approval and Promulgation of State Plans for Designated Facilities and Pollutants; General 

Provisions (40 CFR Part 62, subpart A). 

Section 1 of this document provides an overview of regulatory and State Plan 

requirements; section 2 presents information on the timeline and responsibilities for developing 

and submitting State Plans; and section 3 discusses the required elements of an approvable State 

Plan. The appendices of this document are listed in Table 1-1. The appendices include reference 

materials that states may find useful when revising, amending, or developing their State Plans, 

such as key elements of an acceptable State Plan, clarifications of the applicability of the EG, an 

implementation timeline, contact lists, emission factors (for estimating emissions from HMIWI), 

and copies of relevant regulations. An appendix from the original 1997 guidance document that 

provided answers to questions about the EG and State Plan process is being updated to include 

information about the amended EG and will be provided as a separate document. 

1.2 Clean Air Act Requirements

Section 111(d) has been included in the CAA since the 1970s and requires EPA to 

establish procedures for the submission of State Plans for implementing EG. The first EG 

1-2 
adopted was for sulfuric acid plants in 1977. Other EG have been adopted since that time. The 

State Plans implement and provide mechanisms for enforcing the EG. Section 129 was added to 

the CAA in 1990 and specifically addresses solid waste combustion. It requires EPA to establish 

EG for HMIWI and directs states to develop State Plans for implementing the EG. The 

subpart Ce EG for HMIWI differ from some other EG adopted in the past because the subpart Ce 

EG address both section 111(d) and section 129 requirements. Section 129 overrides some 

aspects of section 111(d). (The subpart Cb EG for Large Municipal Waste Combustors 

[MWCs], subpart BBBB EG for Small MWCs, subpart DDDD EG for Commercial and 

Industrial Solid Waste Incinerators [CISWI], and subpart FFFF EG for Other Solid Waste 

Incinerators [OSWI] similarly address both section 111(d) and section 129 requirements.) 

Table 1-1. Appendices to This Document

Appendix Title 

A 

Key Elements of an Acceptable Section 111(d)/129 State Plan for HMIWI 

B Fact Sheet for Amended Emission Guidelines and NSPS (40 CFR Part 60 

Subparts Ce and Ec) 

C Applicability of the HMIWI Emission Guidelines 

D HMIWI Implementation Timeline 

E EPA Regional and State/Local Agency Contacts 

F HMIWI Emission Factors 

G Clean Air Act Section 111(d) 

H Clean Air Act Section 129 

I 40 CFR Part 60 Subpart B 

J 40 CFR Part 62 Subpart A 

K 

L 

M 

40 CFR Part 60 Subparts Ce (EG) and Ec (NSPS) 

Federal Register Notice for Amended Emission Guidelines and NSPS 

2010 HMIWI Inventory 

Detailed procedures for submitting and approving State Plans under section 111(d) were 

promulgated by EPA in 1975 at 40 CFR Part 60, subpart B and amended in 1979, 1989, 1995, 

2000, 2005, 2006, and 2007. The major revisions to subpart B address differences between 

sections 129 and 111(d) of the CAA. In particular, section 129(b)(2) directs states to submit 

State Plans for HMIWI to EPA within 1 year after promulgation of the EG, whereas the 

subpart B procedures [40 CFR 60.23(a)] developed to implement section 111(d) Plans have a 

1-3 
different schedule. Also, section 129(b)(2) requires section 111(d)/129 State Plans to be “at least 

as protective as the guidelines” in order to be approved by EPA, whereas section 111(d)(1) 

allows states flexibility to consider the remaining useful life of the source and other factors in 

developing State Plans and standards. Where section 129 conflicts with section 111(d), the 

December 19, 1995 revisions to subpart B supersede otherwise applicable requirements of 

subpart B. [60 FR 65414 and 40 CFR 60.23 and 60.24] Table 1-2 addresses the relationship 

between sections 111(d), section 129, and subpart B. 

Table 1-2. Relationship Between Section 111(d), Section 129, and Subpart B

Statutes Rules, Regulations, and Procedures 

Clean Air Act 40 CFR Part 60 

Section 111(b) 

(new sources) 

NSPS→General Provisions→subpart A 

Source category NSPS→subpart D-KKKK 

Section 111(d) 

(existing sources) 

EG→→Procedures (State Plan)→subpart B - amended to allow additional 

directions specified in section 129 

Source category EG→subpart Cb (large MWC), Ce (HMIWI), etc. 

Section 129a Provides more specific directions about complying with sections 111(b) and 111(d) 

for those solid waste combustors listed in section 129 

a

 Section 129 was added with the 1990 Amendments to the CAA. Section 129 changed section 111(d) in the 

following ways: 

● State rule needs to be at least as protective as the EG. 

● Deletes opportunity for sources to have a longer compliance schedule than what the EG specify. Section 

129(f)(2) of the CAA requires expeditious compliance. 

● Allows states a longer time for submittal of their State Plan (i.e., 12 months instead of 9 months). 

The General Provisions associated with the approval and promulgation of State Plans are 

codified in 40 CFR Part 62, subpart A, and each state’s plan is provided in a separate subpart 

under Part 62. (See Appendices G, H, I, and J for the full text of section 111(d); section 129; 40 

CFR Part 60, subpart B; and 40 CFR Part 62, subpart A.) 

1.3 Emission Guidelines

The original EG for HMIWI were promulgated on September 15, 1997, and amendments 

to the EG were promulgated on October 6, 2009. [62 FR 48347 and 74 FR 51368] The EG are 

codified in 40 CFR Part 60, subpart Ce. An outline of the amended EG is presented in Table 1-3. 

The amended EG apply to all existing HMIWI that commenced construction on or before 

June 20, 1996, as well as to those HMIWI that commenced construction after June 20, 1996 but 

no later than December 1, 2008 (i.e., those HMIWI subject to the original NSPS), except where 

1-4 
the emission limits in the original NSPS are more stringent. [40 CFR 60.32e(a)(1) and (2) and 

60.33e(a)(2), (a)(3), and (b)] The pollutants regulated by subpart Ce include metals (cadmium 

[Cd], lead [Pb], and mercury [Hg]); particulate matter (PM); acid gases, (sulfur dioxide [SO2], 

nitrogen oxides [NOx], and hydrogen chloride [HCl]); organic compounds (dioxins and furans); 

carbon monoxide (CO); and opacity. [CAA section 129(a)(4) and (b)(1), Tables 1B and 2B of 

subpart Ce] The amended EG are summarized in a Fact Sheet included in this document (see 

Appendix B). The full text of the amended EG (subpart Ce) is also provided (see Appendix K), 

as well as the October 6, 2009 amendments (see Appendix L). 

Table 1-3. Outline of the Emission Guidelines for HMIWI 

(40 CFR Part 60, Subpart Ce) 

Section Contents 

60.30e Scope 

60.31e Definitions 

60.32e Designated facilities 

60.33e Emission guidelines 

60.34e Operator training and qualification guidelines 

60.35e Waste management guidelines 

60.36e Inspection guidelines 

60.37e Compliance, performance testing, and monitoring guidelines 

60.38e Reporting and recordkeeping guidelines 

60.39e Compliance times 

1.4 Emission Guideline Subcategories

For the amended EG, there were no changes to the HMIWI subcategories that were 

developed for the original EG. The subcategories are based on (1) HMIWI pound per hour 

(lb/hr) capacity to burn hospital waste and medical/infectious waste [40 CFR 60.51c; see 

definitions for “Large HMIWI,” “Medium HMIWI,” and “Small HMIWI”]; and (2) distance 

from the nearest standard metropolitan statistical area (SMSA), as referenced in OMB Bulletin 

No. 93-17, dated June 30, 1993. [40 CFR 60.31e and 60.33e(b)] (Note: Such areas are currently 

referred to as “Metropolitan Statistical Areas (MSAs).”) 

The “small” subcategory consists of HMIWI that burn less than or equal to 200 lb/hr. [40 

CFR 60.51c] The “small” subcategory has been further divided to include a “small rural” 

1-5 
subcategory, which consists of those small HMIWI located in rural areas that burns less than 

2,000 pounds per week of hospital waste and medical/infectious waste. [40 CFR 60.31e and 

60.33e(b)] The “rural criteria” used in determining which small HMIWI are small rural HMIWI 

are presented in sections 60.31e and 60.33e(b) and are further discussed in Appendix C of this 

document. The “medium” subcategory includes HMIWI that burn between 200 and 500 lb/hr, 

and the “large” subcategory consists of HMIWI which burn more than 500 lb/hr. [40 CFR 

60.51c] Hospital/medical/infectious waste incinerator capacity is determined using the methods 

presented in section 60.51c of subpart Ec (see definition for “Maximum design waste burning 

capacity”) and is further discussed in Appendix C of this document. The emission limits in the 

EG are different for each of the HMIWI subcategories. 

1.5 Requirements for State Plans

States are to revise or develop section 111(d)/129 State Plans to implement the amended 

HMIWI EG and to submit their Plans to the appropriate EPA Regional Office for approval. The 

first step for revising or developing such a State Plan is to identify and prepare an updated list of 

sources operating in the state that are subject to the amended EG. [40 CFR 60.25(a)] 

All sources, whether they are on the state’s list or not, are subject to the revised or new 

State Plan and need to be in compliance no later than 3 years following State Plan approval or by 

October 6, 2014, whichever is earlier, under CAA section 129(b)(2) and (f)(2). While not 

required by the EG, in order to cover sources that might be discovered after submittal of the 

revised or new State Plan, EPA recommends that states may want to include certain language in 

the State Plan. Although a state could choose to revise the State Plan in order to establish a 

separate, but equally protective compliance schedule for the newly discovered source, it is not 

necessary, if states choose to include the following (or similar language) in the revised or new 

State Plan: 

1. A statement preceding the inventory which says that sources subject to the 

standard “include, but are not limited to” the inventory in the State Plan; and 

2. In additional statement that says, “Should another source be discovered 

subsequent to this notice, there will be no need to reopen the State Plan.” 

States may also want to include in their revised or new State Plan a generic expeditious 

compliance schedule with which “all other applicable sources” not listed individually in the State 

Plan would need to comply. Any newly discovered source would then be bound to that schedule. 

1-6 
It is possible that HMIWI that are not operating at the time of State Plan submittal could 

reopen as an existing unit in the future. Such a unit would be considered an existing HMIWI, 

assuming it was constructed prior to December 1, 2008.1

 [40 CFR 60.32e(a)(2)] Therefore, EPA 

recommends that states should make a reasonable effort to include sources in the inventory 

which have shut down but that have the potential to reopen. Regarding those HMIWI that 

reopen, EPA suggests for each state the following course of action, based on the original HMIWI 

Federal Plan. [40 CFR 62.14472] The state would submit a revised or new State Plan to require 

retrofit of the necessary air pollution controls before the HMIWI reopens. The revised Plan for 

the non-operating unit would contain a final compliance date and legal authority to ensure that 

the HMIWI would complete retrofit before reopening. As discussed above, the state would not 

revise the State Plan in order to require newly discovered sources to retrofit, but rather, would 

only refer them to the generic compliance schedule contained in the State Plan. If a source were 

discovered well into the compliance time and had already missed several increments of progress, 

it would need to shut down immediately and remain closed until it had caught up with the 

increments. Of course, the state always has the option of assigning a separate compliance 

schedule to that newly discovered source, but in order to do so, the state would need to revise the 

State Plan. 

States which have HMIWI units are directed to submit a revised or new 

section 111(d)/129 State Plan. At a minimum, to be approved by EPA, the State Plan needs to 

include the elements listed below. 

1. A demonstration of the state's legal authority to carry out the section 111(d)/129 

State Plan and identification of enforceable mechanisms, including: 

- a list in the enforcement section of the State Plan indicating the 

consequences for sources not in compliance and the authority under which 

a state can shut down/close a source; 

- a reference to the section 129(f)(3) (“PROHIBITION“) which prohibits a 

plant from operating if it does not comply with the standard; and 

- adequate authority to enforce the recordkeeping and notification 

requirements for co-fired combustors and incinerators burning only 

pathological, low-level radioactive, and chemotherapeutic waste (see 

section 60.32e of subpart(e)). 

 1 If an HMIWI that shut down and reopened had been modified, then it would be 

considered a new source. Modification means any change that results in an increase in emissions 

to the atmosphere or the capital cost of the change is more than 50 percent of the 

inflation-adjusted replacement cost of the HMIWI. [CAA section 129(g)(3) and 40 CFR 60.51c] 

1-7 
[CAA section 129(f)(3) and 40 CFR 60.26(a) and 60.32e(b) and (c)] 

2. An inventory of sources in the state affected by the EG, including to the best of 

the state’s knowledge, HMIWI that have shut down and are capable of restarting, 

and including: 

- a statement preceding the inventory which says that sources subject to the 

standard “include but are not limited to” the inventory in the State Plan, 

and 

 - an additional statement that says, “should another source be discovered 

subsequent to this notice, there will be no need to reopen the State Plan.” 

 [40 CFR 60.25(a)] 

3. An inventory of emissions from HMIWI operating in the state. [40 CFR 60.25(a) 

and (c)] 

4. Emission limits for HMIWI that are at least as protective as those in the EG. 

[CAA section 129(b)(2) and 40 CFR 60.24(a)-(c) and 60.33e] 

5. Testing and monitoring requirements at least as protective as those in the EG. 

[CAA section 129(b)(2) and 40 CFR 60.24(b)(2), 60.25(b), and 60.37e] 

6. Recordkeeping and reporting requirements at least as protective as those in the 

EG. [CAA section 129(b)(2) and 40 CFR 60.25(b)(1) and 60.38e] 

7. Operator training and qualification requirements at least as protective as those in 

the EG. [CAA section 129(b)(2) and (d) and 40 CFR 60.34e] 

8. Inspection requirements at least as protective as those in the EG. [CAA section 

129(b)(2) and 40 CFR 60.25(b)(2), and 60.36e] 

9. Waste management plan requirements at least as protective as those in the EG. 

[CAA section 129(b)(2) and 40 CFR 60.35e] 

10. Compliance schedules (including increments of progress for compliance 

schedules which extend beyond 1 year after State Plan approval). [40 CFR 

60.24(a) and (e)(1) and 60.39e] 

11. An expeditious final compliance date not later than 3 years after approval of the 

revised or new State Plan or October 6, 2014, whichever is earlier.2

 [CAA section 

129(b)(2) and (f)(2) and 40 CFR 60.39e(c)] 

12. A record of public hearing(s) on the State Plan. [40 CFR 60.23(f)(1) and (2)] 

 2

 Final compliance beyond 1 year after State Plan approval is possible only if the State 

Plan contains increments of progress (see Section 3.6). [40 CFR 60.24(e)(1) and 60.39e(c)] 

1-8 
13. Provision for state progress reports to EPA. [40 CFR 60.25(e) and (f)] 

The revised or new State Plans are due to EPA by October 6, 2010. Table 1-4 is a 

crosscheck of subpart B requirements and identifies whether or not each section applies to 

HMIWI. Table 1-4 also indicates where the HMIWI EG (subpart Ce) and section 129 of the 

CAA override specific provisions of subpart B. EPA published guidance for subpart B in 1977. 

That guidance applies to the HMIWI EG, except where overridden by the changes introduced in 

section 129 of the CAA of 1990 and the latest version of subpart Ce. 

Table 1-4. Regulations for Adopting and Submitting State Plans

(40 CFR Part 60 Subpart B)

Section Number 

and Title General Contents Does the Section Apply to HMIWI ? 

60.20 

“Applicability” 

Subpart B applies when final 

Guidelines are promulgated 

(i.e., subpart Ce). 

Yes, final amended HMIWI Guidelines 

(subpart Ce) were published October 6, 2009, 

so subpart B applies to HMIWI. 

60.21 

“Definitions” 

Definitions of key terms. Definition of “designated pollutant” in 

subpart B does not apply to HMIWI. 

Subpart Ce lists nine HMIWI pollutants that 

are covered. 

Definition of “designated facility” in subpart B 

is defined in subpart Ce as each HMIWI for 

which construction commenced on or before 

June 20, 1996 and for which construction 

commenced after June 20, 1996 but no later 

than December 1, 2008. 

60.22 

“Publication of 

guideline documents, 

Emission Guidelines, 

and final compliance 

times” 

Descriptions of contents of 

Emission Guidelines to be 

developed by EPA. 

Yes. Amended guidelines for HMIWI 

(subpart Ce) have been developed and 

published as required (October 6, 2009 [74 FR 

51368]). 

60.23 

“Adoption and 

submittal of State Plans, 

public hearings” 

Schedules and procedures for 

states to follow in developing 

and submitting State Plans. 

Requirements for public hearings 

on State Plans. 

Yes, except for 60.23(a). Section 129 specifies 

that State Plans for HMIWI be submitted 1 year 

after publication of subpart Ce (i.e., October 6, 

2010). 

60.24 

“Emission standards3

and compliance 

schedules” 

State Plans must include 

emission standards and 

compliance schedules. State 

Plans may be more or less 

stringent than the Guidelines. 

Yes, except 60.24(f) does not apply. 

Subpart Ce and Section 129 specify that State 

Plans must be “at least as protective” as the 

Guidelines. 

 3 Note that "emission standards" can include any state enforceable mechanisms including, 

but not limited to, state rules (see section 3.2 in this document). 

1-9 
Section Number 

and Title General Contents Does the Section Apply to HMIWI ? 

60.25 

“Emission inventories, 

source surveillance, 

reports” 

Plans must include a plant 

inventory and an emissions 

inventory and provisions for 

monitoring compliance. States 

must submit progress reports to 

EPA. 

Yes. 

60.26 

“Legal authority” 

Plans must demonstrate that the 

state has legal authority to carry 

out the Plan as submitted. 

Yes. 

60.27 

“Actions by the 

Administrator” 

Procedures for EPA review and 

approval or disapproval of Plans. 

Federal Plans will be developed 

if states have not submitted 

approvable Plans. 

The schedules in 60.27 do not apply. For 

HMIWI, section 129(b)(2) of the Clean Air Act 

allows 6 months for EPA to approve or 

disapprove State Plans. EPA will implement a 

Federal Plan per section 129(b) for all states 

(with affected sources) which do not have an 

EPA approved State Plan in place by October 

6, 2011 (2 years after promulgation). 

60.28 

“Plan revisions by the 

state” 

Procedures for revision of Plans. Yes. 

60.29 

“Plan revisions by the 

Administrator” 

Procedures for revision of Plans. Yes. 

1.6 Requirements for Negative Declarations

If no sources affected by the amended EG in the state, then the state need only submit a 

letter of certification, called a “negative declaration,” to the appropriate EPA Regional 

Administrator in lieu of a revised or new State Plan.4 [40 CFR 60.23(b) and 62.06] EPA has no 

formal review process for negative declaration letters. Once the negative declaration letter is 

received, a copy is placed in the public docket and a notice is published in the Federal Register

(FR). If, at a later date, an existing HMIWI is found in the state, the Federal Plan implementing 

the HMIWI EG would automatically apply to that unit until the State Plan is approved. [40 CFR 

62.14400 and 65 FR 49869-70, 74] If the State Plan is already approved when an existing 

HMIWI is found in the state, the state plan would apply. 

1.7 Relationship Between the Section 111(d)/129 State Plan and SIP

The State Plans for implementing the HMIWI EG are different from State 

Implementation Plans (SIP) required by sections 110 or 172 of the CAA. The State Plan and the 

 4

 The absence of known sources does not preclude a State from submitting a State Plan. 

States with no known sources may still want to submit a State Plan to cover existing sources 

subsequently discovered. 

1-10 
SIP are programs for state implementation of federal requirements, and for both, the 

administrative procedures, particularly the public hearing process, are similar. Both programs 

are designed to achieve emission reductions at sources by identifying the pollutant to be 

controlled, establishing the emission limits for the source, and establishing procedures to ensure 

that emission limits are met. 

However, the states and EPA fulfill different responsibilities under the two programs. 

The goal of section 111(d)/129 State Plans is to control the emissions of designated pollutants5

by establishing standards of performance for existing sources. Section 111(d)/129 EG (including 

emission limits or performance levels) are technologically-based and are established by EPA on 

a national level. States are responsible for developing and implementing a program to achieve 

compliance with these technologically-based standards. 

The goal of the SIPs, on the other hand, is to attain and maintain National Ambient Air 

Quality Standards (NAAQS) or ambient concentrations for certain criteria pollutants (Pb, SO2, 

PM10, NO2, CO, and ozone) in a given area. Hence, in the SIP program, the state establishes 

emission limits or standards based on the sources' contributions to local air quality and other 

local factors. The emission control requirements for a regulated source category under a SIP 

may vary from facility to facility based on local factors. The states are responsible for 

implementing both section 111(d)/129 State Plans and SIP programs, and both programs 

complement each other. 

 5 Section 111(d)/129 Plans apply to PM, SO2, HCl, CO, NOx, Pb, Cd, Hg, dioxins/furans, 

and opacity (as appropriate) [CAA section 129(a)(4) and (b)(2)]. 

1-11 
1-12 
2.0  Schedule and Responsibilities

Sections 111(d) and 129 of the CAA direct each state to adopt and submit Plans that 

implement the HMIWI EG within 1 year after EPA publication of the final EG. [CAA sections 

111(d)(1) and 129(b)(2)] Amended EG for HMIWI (40 CFR Part 60, subpart Ce) were 

published on October 6, 2009 [74 FR 51368], and revised or new State Plans need to be 

submitted to EPA on or before October 6, 2010 [CAA section 129(b)(2) and 40 CFR 

60.39e(a)(2)]. Figure 2-1 is a timeline which shows how implementation of the EG might 

proceed if the maximum time allowed is used for each event. 

2.1 State Plan Schedule

In order to submit a revised or new section 111(d)/129 State Plan by October 6, 2010, 

States need to revise an existing or develop a new section 111(d)/129 State Plan as soon as 

possible and complete the required public hearings. The steps that are necessary for states to 

develop and submit the State Plans are listed in Table 2-1, along with an example schedule. 

After the revised or new State Plan is submitted, EPA is required to approve or 

disapprove the State Plan no later than 180 days (6 months) of State Plan submittal. [CAA 

section 129(b)(2)] EPA’s decision to approve or disapprove each State Plan will be published in 

the FR. [40 CFR 62.02(e) and 62.04] Final decisions will be codified in 40 CFR Part 62, 

“Approval and Promulgation of State Plans for Designated Facilities and Pollutants.” If a 

revised or new State Plan is not approvable, EPA will discuss its concerns about the State Plan 

with the state prior to official disapproval. If the State Plan is not approved, the basis for 

disapproval will be discussed in the FR notice, and the state would have an opportunity to submit 

a revised Plan addressing EPA’s concerns. [CAA section 129(b)(2) and 40 CFR 62.02(e) and (f)] 

If the state does not have an approved Plan in place by October 6, 2011, EPA’s Federal Plan will 

go into effect immediately and will be applicable to affected sources in that state. [CAA section 

129(b)(3) and 40 CFR 62.13 and 60.39e(f)] 

2-1 
Compliance Window

Increments of progress 

required6

1 74 FR 51368.2 Section 129(b)(2) requires State Plans be submitted not later than one year after promulgation of the rule.3 Section 129(b)(2) requires EPA to approve or disapprove a State Plan within 180 days of submission.4 Section 129(b)(3) requires EPA to develop a Federal Plan within 2 years of rule promulgation (if necessary).5 Due 12 months after EPA approval of State Plan under section 60.39e of subpart Ce unless the State has granted an extension to a s

approval of State Plan but not less than 5 years after promulgation). Note: Section 129(f)(2) requires expeditious compliance.

6 Section 60.24(e)(1) of subpart B requires legally enforceable increments of progress for any compliance schedule extending beyond 

approval. Section 60.39e(c)(1)-(9) of subpart Ce and section 60.21 of subpart B list suggested increments of progress, and section 60

required increments of progress.Notes:

Subpart B General requirements for all section 111(d) State Plans. Amended 12/19/95 to allow subsequent subparts (e.g., subpa

supersede subpart B.

Subpart Ce Emission Guidelines for HMIWI.

10/6/2010

State Plans

Due2

10/6/2011

Federal Plan

Published4

10/6/2009

Revised Rule

Promulgated1

4/6/2011

EPA Approves/

Disapproves

State Plans3

4/6/2012

Compliance Due5

Figure 2-1. HMIWI Implementation Timeline 

2-2 
Table 2-1. Sample State Schedule for Section 111(d)/129 State Plans

Action Date 

Begin source inventory Immediately 

Amended EG promulgated by EPA October 6, 2009 

Decide what state authority to use November 2009 

Start state rulemaking or other procedure needed to ensure 

state authority 

December 2009 

Start revising or drafting State Plan December 2009 

Notice of public hearings February 2010 (30 days before 

hearing) 

Complete state rulemaking or other procedure needed June 2010 

Complete public hearing on revised or new State Plan June 2010 

Revised or new State Plans due to EPA Regional Office October 6, 2010 

Respond to any clarifications requested by EPA During the 180 day period 

following October 6, 2010 

EPA approval/disapproval of the revised or new State Plan No later than 6 months after 

State Plan submittal 

If disapproved, submit revised approvable State Plan Prior to October 6, 2011 to 

avoid Federal Plan 

Federal Plan (if applicable) October 6, 2011 

To be approved by EPA, the revised or new section 111(d)/129 State Plans need to 

include a compliance schedule for all existing HMIWI located in the state. [40 CFR 60.24(a) and 

60.39e] The compliance schedule should require compliance as expeditiously as practicable 

after EPA approval of the Plan and can allow up to 3 years from State Plan approval for HMIWI 

to comply, provided the State Plan includes enforceable increments of progress. [40 CFR 

60.24(e)(1) and 60.39e(c)] In all cases, all applicable sources need to be in compliance no later 

than 3 years after State Plan approval by EPA or October 6, 2014, whichever is earlier. [CAA 

section 129(b)(2) and (f)(2) and 40 CFR 60.39e(c)] Compliance could be achieved by 

completing a retrofit of air pollution controls or by shutting down. [see 40 CFR 62.14470 and 

62.14471 of the original HMIWI Federal Plan as an example] States may establish compliance 

schedules that are shorter than the times allowed by the EG, but they may not establish 

2-3 
compliance schedules that are longer than allowed by the EG. [CAA section 129(b)(2) and 

40 CFR 60.24(g) and 60.39e(b)-(d)] 

2.2 Responsibilities

EPA, the states, and owners and operators of HMIWI each have responsibilities for 

implementing the EG. The primary responsibilities for each party are outlined below. 

2.2.1 EPA Responsibilities

Assisting State and Local Programs and HMIWI Owners and Operators. EPA 

assists state and local agencies to prepare revised or new, approvable section 111(d)/129 State 

Plans. EPA provides information, answers questions, and interprets federal requirements for the 

state and for HMIWI owners and operators. EPA conducts outreach and compliance assistance 

programs. EPA identifies contact persons to answer states’ questions, clarify approval criteria, 

and address specific implementation issues as necessary. States’ questions should be directed to 

the appropriate EPA Regional Office to ensure efficient and consistent responses. (See 

Appendix E for a list of Regional and state contacts.) 

Review of State Plans. Section 129(b)(2) of the CAA requires EPA to approve or 

disapprove State Plans within 180 days (6 months) of submittal. States are to revise or develop 

their section 111(d)/129 State Plans pursuant to 40 CFR Part 60, subpart B (as revised December 

19, 1995 to conform with section 129). EPA will inform the state if EPA has questions about the 

revised or new State Plan before making a decision on the approval or disapproval of the State 

Plan. After a state incorporates a requirement in the revised or new State Plan, and the State Plan 

is reviewed and approved by EPA, the state requirement becomes federally enforceable. 

Federal Plan. EPA anticipates that many of the states with HMIWI will prepare revised 

or new, approvable section 111(d)/129 State Plans. In the event an approvable State Plan is not 

submitted, EPA will develop and implement a Federal Plan, which will go in effect immediately 

on October 6, 2011 for any state that does not have an approved State Plan. 

Tribal Plans No existing HMIWI are located on tribal lands. EPA does not anticipate 

the need for any tribes to develop Tribal Plans. 

2-4 
2.2.2 State Responsibilities

Developing a State Plan. The state is to revise or develop a State Plan that meets the 

criteria presented in sections 111(d) and 129 and the amended EG. This document discusses 

how states could meet this responsibility. 

Establishing Compliance Schedules. To be approved by EPA, the revised or new State 

Plan needs to include the amended emission limits and compliance schedules for all HMIWI. 

When preparing a revised or new section 111(d)/129 State Plan, states should contact HMIWI 

owners and operators to ensure that they understand the requirements of the amended EG. 

Facilities could come into compliance with the State Plan by completing a retrofit or shutting 

down by the 1-year compliance date (i.e., 1 year after EPA approval of the State Plan). [40 CFR 

60.39e(b)] If the revised or new State Plan contains increments of progress (see section 3.6), 

HMIWI may be allowed to extend their retrofit schedule beyond the 1-year compliance date. [40 

CFR 60.24(e)(1) and 60.39e(c)] All HMIWI planning to retrofit would need to do so within 

3 years of EPA approval of the revised or new State Plan, but no later than October 6, 2014. 

[CAA section 129(b)(2) and (f)(2) and 40 CFR 60.39e(c)] All HMIWI planning to shut down 

would need to do so within 1 year after EPA approval of the revised or new State Plan, unless 

granted an extension by the state under the provisions of section 60.39e(d) of subpart Ce. Be 

aware that a state can only consider petitions per section 60.39e(d) if the State Plan includes a 

provision that allows such sources to request an extension to continue operating beyond 1 year 

after State Plan approval (see section 3.6). [40 CFR 60.24(a) and (e)(1) and 60.39e(c) and (d)] 

Ensuring Compliance. Facilities could achieve compliance by completing retrofits or 

shutting down by the dates established in the revised or new section 111(d)/129 State Plans. [see 

40 CFR 62.14470 and 62.14471 of the original HMIWI Federal Plan as an example] In order to 

prevent sources from continuing to operate or restarting without proper controls, the revised or 

new State Plans need to demonstrate the legal authority requiring HMIWI that have shut down to 

maintain closure. [40 CFR 60.26(a)] States are advised to include a generic compliance schedule 

in their revised or new State Plans to cover facilities which have shut down but may reopen in 

the future. Units that shut down by the date 1 year after EPA approval of the revised or new 

State Plan, and restart prior to the October 6, 2014 deadline would need to complete all of the 

missed increments of progress in the state’s generic compliance schedule before restarting. [40 

CFR 60.24(e)(1) and 60.39e(c); see 40 CFR 62.14472 of the original HMIWI Federal Plan as an 

2-5 
example] Units which restart after the October 6, 2014 compliance deadline would need to 

comply with the revised or new State Plan before resuming operation. [CAA section 129(f)(3) 

and 40 CFR 60.26(a); see 40 CFR 62.14472 of the original HMIWI Federal Plan as an example] 

Hospital/medical/infectious waste incinerators that shut down can be divided into two 

groups. The first group is HMIWI that have shut down or will shut down and are not planning to 

restart. Once shut down, such sources cannot restart without a State Plan revision and retrofit of 

air pollution control equipment. [40 CFR 60.24(e)(1), 60.25(a), 60.28(c), and 60,39e(b) and (c); 

see 40 CFR 62.14471 of the original HMIWI Federal Plan as an example] 

The second group is HMIWI that shut down as an element of their retrofit activities. For 

these HMIWI, schedules for shutdown and completion of retrofit activities would be included in 

the revised or new State Plan. For retrofitting facilities, the revised or new State Plan needs to 

include the five enforceable increments of progress for retrofit activities (discussed in 

section 3.6.3), along with a sixth increment, a date for shutdown. Under the State Plan, the 

HMIWI would shut down by the specified date and could not restart until the other increments of 

progress, including retrofit of controls, are complete. [40 CFR 60.24(e)(1) and 60.39e(c); see 

40 CFR 62.14470 and 62.14472 of the original HMIWI Federal Plan as an example] 

Submitting Progress Reports. States are to report annually to EPA on the progress of 

implementing the revised or new Plan, including meeting increments of progress and achieving 

final compliance. The States also need to include in this report (as discussed in section 3.12): 

(1) compliance status, (2) enforcement actions, and (3) updates on inventory. [40 CFR 60.25(e) 

and (f)] 

2.2.3 Source Responsibilities

Developing Compliance Plans and Schedules. Hospital/medical/infectious waste 

incinerator owners and operators are to work with the state to develop a compliance plan and 

retrofit schedule under the revised or new State Plan. [40 CFR 60.39e(d)(1)(i) and (ii)] To 

comply, all HMIWI will need to either shut down within 1 year of EPA approval of the State 

Plan1 or complete retrofits to comply with the emission limits not later than 3 years after 

 1

In some cases, sources planning to shut down may be granted an extension beyond the 

1-year deadline, if the State Plan contains the provisions outlined in section 60.39e(d) of 

subpart Ce. 

2-6 
2-7 

approval of the revised or new section 111(d)/129 State Plan or by October 6, 2014, whichever is 

sooner. [CAA section 129(b)(2) and (f)(2) and 40 CFR 60.39e(b)-(d); see 40 CFR 62.14470 and 

62.14471 of the original HMIWI Federal Plan as an example] 

Upgrading or Retrofitting Facilities. Owners and operators will need to retrofit or 

upgrade their facilities to meet the amended emission limits on the compliance schedules 

established by the state. [CAA section 129(b)(2), (f)(2), and (f)(3) and 40 CFR 60.24(a), (c), and 

(e)(1) and 60.39e(b)-(d)] 

Meeting Additional State Plan Requirements. In addition to completing the necessary 

retrofits, owners and operators are responsible for meeting other State Plan requirements 

(summarized in section 3.5). Facilities are required to comply with operator training and 

qualification requirements, inspection requirements, and waste management plan requirements. 

[40 CFR 60.25(b) and 60.34e-60.36e] Facilities are to report to the state their progress towards 

compliance, report ongoing testing and monitoring results, and keep required records to 

demonstrate compliance. [40 CFR 60.25(b), 60.37e, and 60.38e] Most of these requirements are 

to be completed at the time of full compliance, with the exception of the operator training and 

qualification requirements and the inspection requirements, which are to be completed within 

1 year after EPA approval of the revised or new State Plan. [40 CFR 60.34e, 60.36e(a) and (c), 

and 60.39e(e)] 

3.0  Required Elements of an Acceptable State Plan

Table 3-1 summarizes the elements of the State Plan for HMIWI, provides citations from 

subparts B and Ce, and identifies the sections of this chapter that discuss each element. States 

may find this summary helpful in preparing their revised or new section 111(d)/129 State Plans, 

and EPA will use it in reviewing the State Plans. 

Some components of a section 111(d)/129 State Plan duplicate existing state 

requirements and, therefore, will not add additional requirements. For example, most states 

require public notice for rulemaking consistent with 40 CFR Part 60, subpart B. Similarly, 

section 112 and title V of the CAA require various demonstrations of legal authority. To the 

extent that earlier demonstrations of legal authority by the state meet the requirements of 40 CFR 

Part 60, subpart B, the state would simply need to include copies of such demonstrations in the 

State Plan submittal, including a copy of the state laws or regulations (if applicable). 

3.1 Demonstration of Legal Authority

To be approved by EPA, the section 111(d)/129 State Plan needs to demonstrate that the 

state has the legal authority under current state law to adopt and implement the emission 

standards and compliance schedules in the State Plan. [CAA section 129(f)(3) and 40 CFR 

60.26(a)] The legal authority should support the legal mechanism selected by the state to 

implement the emission limits for HMIWI. The legal authority needs to be available to the state 

at the time the state submits its section 111(d)/129 State Plan to EPA. [40 CFR 60.26(c)] States 

are to submit with the section 111(d)/129 State Plan copies of the laws or regulations that 

demonstrate the state's legal authority if a state law or regulation is the enforceable mechanism. 

[40 CFR 60.26(b)]1 

A state could use existing demonstrations of legal authority to meet the requirements of 

subpart B. Which existing authorities the state uses to implement the section 111(d)/129 

requirements depends on the legislative structure of the state. This implementation guidance 

discusses the minimum requirements of section 111(d) and 129 pertaining to HMIWI and notes 

 

1 Only citations from the overall rule and copies of the sections pertaining to HMIWI would need to be submitted. 

[40 CFR 60.26(b), noting that the “provisions of law or regulations...shall be specifically identified.” (emphasis 

added)] 

3-1 
that states retain flexibility to implement the requirements as long as the provisions are 

enforceable under state law. 

Table 3-1. Summary of Requirements for Section 111(d)/129 State Plansa

Required Item Reference in 40 CFR Part 60, 

Subpart B or Ce

Section of this 

Document

Demonstration that state has legal authority to 

carry out Plan

60.26(a) of subpart B 3.1

Enforceable mechanisms selected by the state to 

implement the Guidelines

60.24(a) of subpart B 3.2

Inventory of HMIWI, their emissions and 

information related to their emissions

60.25(a) and (c) of subpart B 3.3

Compliance with emission limits 60.24(a)-(c) of subpart B and 

60.33e of subpart Ce

3.4

Provisions for determining HMIWI compliance 

status, including:

1. Legally enforceable procedures for requiring 

the maintenance of records and periodic reporting 

to the state for the determination of compliance;

2. Periodic inspections and testing;

3. Testing, monitoring, recordkeeping, and 

reporting requirements specified in subpart Ce;

4. Operator training and qualification;

5. Waste management plan; and

6. Inspections

60.24(b)(2) and 60.25(b) of 

subpart B and 60.34e-60.38e 

of subpart Ce

3.5

Compliance schedules and legally enforceable 

increments of progress for HMIWI to achieve 

compliance

60.24(a) and (e)(1) of 

subpart B and 60.39e of 

subpart Ce

3.6

Certification that a public hearing was held 

before the State Plan was adopted and list of the 

attendees at the hearing and their affiliation, with 

a summary of their presentations and handouts

60.23(f)(1) and (2) of 

subpart B

3.7

State progress reports 60.25(e) and (f) of subpart B 3.8

a

 See text of section 3 and Appendix A of this document for additional discussion of the required 

elements of a State Plan. 

A state needs to include in its demonstration of existing legal authority a showing that it 

has the authority to: 

1. Adopt emission standards (including stack opacity) and enforceable conditions 

(see section 3.2) as well as compliance schedules applicable to the designated 

facilities and pollutants for which the section 111(d)/129 State Plan is submitted; 

[40 CFR 60.26(a)(1), 60.33e, and 60.39e] 

3-2 
2. Enforce the relevant laws, regulations, standards and compliance schedules 

referenced in section 111(d) and section 129 and seek injunctive relief and 

prevent restart of HMIWI that have shut down; [40 CFR 60.26(a)(2)] 

3. Obtain information necessary to determine compliance; [40 CFR 60.26(a)(3)] 

4. Require reporting and recordkeeping, operator training and qualification, 

inspections, and testing; [40 CFR 60.26(a)(3), 60.34e, and 60.36e-60.38e] 

5. Require the use of monitors and require emission reports of HMIWI 

owners/operators; [40 CFR 60.26(a)(4) and 60.37e] 

6. Make emission data available to the public; [40 CFR 60.26(a)(4)] and 

7. Require a waste management plan. [40 CFR 60.35e] 

Demonstrations of legal authority can take several forms. States that use a legal 

mechanism other than rulemaking to implement the EG should submit legal documentation, 

preferably an opinion by the state's Attorney General, that the state possesses the adequate 

authority to implement and enforce the section 111(d)/129 State Plan using that legal 

mechanism. [CAA section 114(b)(1) and 40 CFR 60.26] 

A state governmental agency other than the state air pollution control agency may be 

assigned responsibility for carrying out a portion of a section 111(d)/129 State Plan, provided 

that the state demonstrates that the state governmental agency has adequate authority. 

[40 CFR 60.26(d)] The state may authorize a local agency to implement a portion of the 

section 111(d)/129 State Plan, provided that the local agency demonstrates that it has adequate 

legal authority to implement that portion of the State Plan and the state is not relieved of 

responsibility. [40 CFR 60.26(e)] 

3.2 Enforceable Mechanisms

Many states that have HMIWI covered by the amended EG will revise existing or 

develop new section 111(d)/129 State Plans that use state rules as the legal instrument to enforce 

the amended EG. An essential element of a section 111(d)/129 State Plan is the emission 

standards, which 40 CFR 60.21(f) defines as “a legally enforceable regulation (emphasis added) 

setting forth an allowable rate of emissions into the atmosphere, or prescribing equipment 

specifications for control of air pollution emissions.” 

3-3 
Note that the pollutants regulated under the amended HMIWI EG are a combination of 

criteria and hazardous air pollutants. Generally, states have adequate authority under their air 

pollution statutes to regulate both criteria pollutants and hazardous air pollutants through a 

variety of mechanisms. 

If the state relies on a mechanism that is not a state rule to implement the amended EG, 

the state needs to document in the State Plan how the selected mechanism ensures that the 

HMIWI will meet the requirements of the amended EG and attach a copy of the enforceable 

mechanism. [CAA section 114(b)(1), 40 CFR 60.26(b)] To ensure that the selected mechanism 

meets all of the requirements of the EG, the State would need to legally certify (preferably an 

Attorney General’s Opinion) that the selected mechanism can be used to create enforceable 

requirements under the EG. Given that a process other than a rulemaking is being used to create 

federally-enforceable requirements, the State would also need to explain how the public has had 

an opportunity to participate in the development of the EG requirements, how the mechanism is 

permanent, and how the public will have access to the underlying documents which contain the 

limits and requirements. 

The selected enforcement mechanism should not be title V permits because title V 

permits could not be used to create applicable federal requirements from the emission guidelines, 

title V permits are not permanent, and the public participation process under the EG is distinct 

from title V public notice requirements. Additionally, it is important to note that Attorney 

General Opinions submitted as part of title V program submittals would not be able to address 

the issues resulting from a State selecting an enforceable mechanism other than a rule to 

implement the EG. 

3.3 Inventory

3.3.1 Source Inventory

A complete, updated source inventory of affected HMIWI in the state regulated by the 

EG is to be submitted as part of the state’s revised or new section 111(d)/129 State Plan. 

[40 CFR 60.25(a)] Sources affected by the EG that will need to be included in the state’s source 

inventory include: (1) HMIWI, (2) co-fired combustors, and (3) incinerators burning only 

pathological, low-level radioactive, and chemotherapeutic waste alone or in combination. 

[40 CFR 60.25(a) and 60.32e(a)-(c)] Each of these three types of combustors are defined in 

3-4 
section 60.51c of subpart Ec. The HMIWI are subject to all of the subpart Ce requirements. 

Co-fired combustors and incinerators burning pathological, low-level radioactive, and 

chemotherapeutic waste are only required to notify the Administrator of an exemption claim and 

to keep certain records. [40 CFR 60.32e(b) and (c)] Nevertheless, these sources are affected by 

the EG and thus, will need to be included in the source inventory. [40 CFR 60.25(a)] In addition, 

States are encouraged to make a reasonable effort to include sources which have shut down their 

incinerator, but which still have the capability of resuming operation. 

In cases where a facility has shut down its HMIWI and does not intend to resume 

operation, the HMIWI may be left off of the state’s source inventory if the state determines that 

the HMIWI is inoperable. [40 CFR 60.25(a); see also 65 FR 49876, in the preamble to the 

original HMIWI Federal Plan] Criteria for determining whether an incinerator is inoperable 

could include, but are not limited to, one or more of the following conditions: 

1. Waste charge door welded shut 

2. Stack/by-pass stack removed 

3. Combustion air blowers removed 

4. Burners or fuel supply removed 

[65 FR 49876] 

States should use their best judgment to ensure that a facility has taken steps to render the 

HMIWI inoperable before omitting the HMIWI from their source inventory. 

3.3.2 Emission Inventory

An updated emission inventory, based on the updated HMIWI source inventory, for the 

pollutants regulated by the EG, is required by 40 CFR 60.25(a) and is to be included in the 

state’s revised or new section 111(d)/129 State Plan. The emission inventory, as well as the 

source inventory, is to be made available to the public at the public hearing and presented with 

the applicable emission standards. [60.23(d)(2)] The inventory data should include emission 

data for the designated pollutants (e.g., continuous emission monitoring system [CEMS] data, 

actual test data, or recent estimates of emissions where practicable). [40 CFR 60.25(a) and Part 

60 Appendix D] Means of estimating emissions from HMIWI are readily available and are 

discussed in section 3.4.1 below and in Appendix F. It may be more difficult to estimate 

emissions from co-fired combustors and incinerators burning only pathological, low-level 

radioactive, and chemotherapeutic waste due to the mixtures of wastes combusted. Unlike 

HMIWI, co-fired combustors and incinerators burning pathological, low-level radioactive, and 

3-5 
chemotherapeutic waste are not required to be subject to the emission limits in the State Plan. [40 

CFR 60.32e(b) and (c)] Therefore, while states should include these sources in their source 

inventories, states could elect to leave these units out of the emission inventory. [40 CFR 

60.25(a) and 60.32e(a)] Likewise, States could choose to leave incinerators which have shut 

down out of their emission inventory, since these sources would have zero emissions. [40 CFR 

60.25(a); see also 65 FR 49876, in the preamble to the original HMIWI Federal Plan, as an 

example] 

3.3.2.1 Emission Estimation Methods

Estimates of emissions for the emission inventory can be derived from a variety of 

methods. To the degree that a variety of types of data are available, EPA recommends the 

following hierarchy for estimating emissions2

: 

1st choice. Where already available, CEMS data that provide a continuous record of 

emissions over an extended and uninterrupted period of time. 

2nd choice. Where already available, stack sampling results. 

3rd choice. Emission factors: 

a. AP-42/FIRE3 emission factors rated "A" through "D"--based on source 

tests performed at one or more facilities within an industry ("A" is the 

highest rating) or EPA emission factors generated from data used in the 

development of the amended HMIWI EG (presented in Appendix F). 

b. State emission factors--possibly more optimized to local or regional 

conditions. 

c. Industry emission factors. 

d. AP-42/FIRE emission factors rated "E" and "U" ("E" is the lowest rating 

on the A through E scale, and "U" is unratable). 

Where emission factors are used, the AP-42 Compilation of Air Pollutant Emission 

Factors provides preferred emission estimation methods. Example calculations for estimating 

emissions from emission factors are provided in AP-42. However, where emissions data from 

 

2Chapter 4, Introduction to Stationary Point Source Emission Inventory Development, 

May 2001. http://www.epa.gov/ttn/chief/eiip/techreport/volume02/ii01_may2001.pdf 3

 AP-42 is the common name for the EPA document entitled Compilation of Air Pollutant 

Emission Factors, Volume I: Stationary Point and Area Sources, Fifth Edition, January 1995, 

available from GPO or from the CHIEF bulletin board. The Factor Information Retrieval System

(FIRE) is factor retrieval software that is available from the CHIEF bulletin board or by calling 

Info-CHIEF hotline at (919) 541-5285. 

3-6 
CEMs or stack testing are already available and are thought to be representative, the data should 

be used in place of emission factors. Additional testing would not be needed for the inventory in 

the State Plan where data are not available. [40 CFR 60.25(a) and Part 60 Appendix D] 

3.3.2.2 Required Emission Summary Reports

A summary of emissions should be submitted with the revised or new section 111(d)/129 

State Plan. The summary should include, at a minimum, the emission rate of each of the 

designated pollutants for each HMIWI. These values should be provided with the corresponding 

emission standards to show the relationship between measured or estimated emissions and the 

amounts of such emissions allowed by the standard. [40 CFR 60.25(a)] 

3.3.2.3 Annual Emission Reporting

In addition to the updated emission inventory required for the revised or new 

section 111(d)/129 State Plan, 40 CFR 60.25(e) also requires states to submit reports on progress 

in plan enforcement, as part of the annual report to EPA submitted under 40 CFR 51.321 through 

51.323. These annual reports are to update the emission inventory for sources that achieve 

compliance, sources that are new or modified, sources that have shut down, and sources whose 

emissions have changed more than 5 percent from the most recently submitted emission data. [40 

CFR 60.25(f)(4) and (5)] If none of the above events occurs, then there are no updates to report, 

and the only change the state would need to make to the next annual report would be to change 

the year (i.e., the state could still use the data from the previous year). [40 CFR 60.25(f)(5)] 

3.3.2.4 Reporting to AFS

Emissions data are to be reported to the Air Facility System (AFS) as specified in 

paragraph (a) of Appendix D to 40 CFR Part 60. The AFS is a repository of emission 

information for stationary sources that supersedes the National Emissions Data System (NEDS) 

described in 40 CFR Part 60 Appendix D. 

3.4 Compliance with Emission Limits

Hospital/medical/infectious waste incinerators will need to retrofit controls to comply 

with the emission limits in the revised or new State Plan or shut down their incinerator. The 

revised or new State Plan should include emission limits that are at least as protective as the 

amended EG and also should address non-operating HMIWI (unless the HMIWI is inoperable) 

3-7 
and HMIWI that will shut down rather than retrofit air pollution control equipment. [CAA 

section 129(b)(2), 60.24(c), 60.25(a), and 40 CFR 60.33e(a)] The emission limits are to apply at 

all times, including periods of startup, shutdown, and malfunction, as defined in subpart Ce. [40 

CFR 60.37e(a) and 60.56c(a)] 

Under section 129(b)(2), the revised or new section 111(d)/129 State Plans are to include 

emission limits that are “at least as protective as” those in the amended HMIWI EG (40 CFR 

Part 60, subpart Ce). The emission limits for the nine HMIWI pollutants and opacity are found 

in subpart Ce (presented in Appendix K of this document). 

The revised or new section 111(d)/129 State Plan should include limits for all nine of the 

pollutants plus opacity in subpart Ce. Section 60.33e of subpart Ce specifies emission limits for 

PM, CO, Cd, Pb, Hg, SO2, HCl, dioxins/furans, NOX, and opacity. All of these pollutant limits 

are in units of concentration. For example, the PM and metals limits are in units of milligrams 

per dry standard cubic meter exhaust. The dioxins/furans limit is also a concentration limit (in 

units of nanograms per dry standard cubic meter) for total dioxins/furans and the toxic equivalent 

[TEQ] for 2,3,7,8-tetrachlorodibenzo-p-dioxin [TCDD]). The HCl, SO2, NOx, and CO limits are 

concentration limits in units of parts per million by volume. The opacity limit is in units of 

percent opacity. 

To be approvable, the revised or new section 111(d)/129 State Plan should include 

emission limits in dimensions identical to the amended Guidelines, or alternative formats 

demonstrated to be at least as protective as the concentration limits specified for each pollutant in 

subpart Ce. [CAA section 129(b)(2) and 40 CFR 60.24(c) and 40 CFR 60.33e(a)] Other state 

programs and permits may include limits in the form of emission rates (e.g., pounds per hour) or 

ambient air concentrations; these types of limits are not required to be included in the revised or 

new section 111(d)/129 State Plan. If a revised or new State Plan uses any format for emission 

limits other than those in subpart Ce, the state needs to demonstrate to EPA that these emission 

limits are at least as protective as those in subpart Ce. [CAA section 129(b)(2) and 40 CFR 

60.24(c) and 40 CFR 60.33e(a)] 

3-8 
3.5 Determining HMIWI Compliance Status

To be approved by EPA, the revised or new section 111(d)/129 State Plan needs to 

include requirements for the testing and monitoring, reporting and recordkeeping, operator 

training and qualification, waste management plans, and the inspection provisions from the EG. 

These provisions are specified in the amended HMIWI EG (subpart Ce). These include, 

in particular: 

1. The performance testing methods listed in section 60.56c of subpart Ec 

[40 CFR 60.37e], 

 

2. The monitoring requirements listed in section 60.57c of subpart Ec [40 CFR 

60.37e], 

3. The reporting and recordkeeping provisions listed in section 60.58c of subpart Ec 

[40 CFR 60.38e], 

4. The operator training and qualification requirements listed in section 60.53c of 

subpart Ec [40 CFR 60.34e], 

5. The waste management guidelines listed in section 60.55c of subpart Ec [40 

CFR 60.35e], and 

6. The inspection guidelines listed in section 60.36e of subpart Ce. 

The amended EG include periodic performance tests and monitoring of specific operating 

parameters. [40 CFR 60.37e(a)-(e), 60.56c(c), and 60.57c(a)-(e)] Each facility is to maintain 

records of the performance test and specified operating parameters for 5 years. [40 CFR 

60.38e(a) and 60.58c(b)(2) and (6)] The facility is to submit annual reports if it is in compliance 

and semiannual reports if it exceeds emission standards or operating parameter limits. [40 CFR 

60.38e(a) and (b)(2) and 60.58c(d) and (e)] Details of these requirements are contained in 

subpart Ce (presented in Appendix K of this document). 

A revised or new State Plan that incorporates the testing, monitoring, reporting, and 

recordkeeping requirements specified in subpart Ce will be consistent with the State Plan 

requirements in subpart B. Under section 60.25(b) and (c) of subpart B, State Plan requirements 

for monitoring compliance are to include the following: 

1. Legally enforceable requirements that require owners and operators to keep 

records of the nature and amount of emissions and any other information that may 

be necessary to enable the state to judge compliance. This information is to be 

3-9 
reported periodically to the state. [40 CFR 60.25(b)(1)] (Subpart Ce requires such 

records and reports.) 

2. Legally enforceable requirements that provide for periodic inspection and testing. 

[40 CFR 60.25(b)(2)] (Subpart Ce requires periodic testing and monitoring of 

operating parameters.) 

3. Provisions for making reports of emissions, correlated with the emission 

standards that apply available to the general public. [40 CFR 60.25(c)] 

In addition, State Plan provisions for testing and monitoring are to be conducted in accordance 

with the quality assurance procedures in 40 CFR part 60, Appendix F, and in the underlying test 

methods. 

3.5.1 Testing Requirements

 Consistent with Section 60.37e of the amended subpart Ce EG, revised or new State 

Plans are to require all HMIWI, including small rural HMIWI, to demonstrate initial compliance 

with the 2009 amended emission limits for all nine pollutants and opacity, if the sources have not 

already demonstrated compliance. Revised or new State Plans may allow sources to use results 

of their previous emission tests to demonstrate initial compliance with the amended emissions 

limits as long as the sources certify that the previous test results are representative of current 

operations with regard to factors such as charge rate, operating parameters, etc. [40 CFR 

60.37e(f)] Only those sources who could not so certify and/or whose previous emission tests do 

not demonstrate compliance with one or more amended emission limits would need to conduct 

another emission test for those pollutants. [40 CFR 60.37e(a)(2), (b)(2), and (f) and 60.56c(b)] 

Revised or new State Plans are also to require all HMIWI, including small rural HMIWI, to 

demonstrate annual compliance with the amended PM, CO, and HCl emission limits by 

conducting an annual performance test. [40 CFR 60.37e(a)(2) and (b)(2) and 60.56c(c)(2)] In 

addition, revised State Plans are to require existing HMIWI to conduct a Method 22 visible 

emissions test of the incinerator ash handling operations during the next performance test at the 

facility. State Plans for new HMIWI are to require a Method 22 visible emissions test of the 

incinerator ash handling operations during each compliance test. [40 CFR 60.37e(a)(2) and (b)(2) 

and 60.56c(b)(14)] 

3.5.2 Monitoring Requirements

 Revised or new State Plans are to require sources to establish site-specific operating 

3-10 
parameter limits during the performance tests to demonstrate initial compliance with amended 

emission limits, as well as to require sources to monitor those operating parameters to ensure 

ongoing compliance. Section 60.37e of the amended subpart Ce EG specifies the types of 

operating parameters to be monitored. Revised or new State Plans may also include the use of 

CO, PM, HCl, multi-metals, and Hg CEMS and integrated sorbent trap Hg monitoring and 

dioxin monitoring (i.e., continuous sampling with periodic sample analysis) as alternatives to 

parameter monitoring. [40 CFR 60.37e(a)(2) and (b)(2) and 60.56c(c)(4)-(7)] 

3.5.3 Reporting and Recordkeeping Requirements

 Revised or new State Plans are to include the reporting and recordkeeping requirements 

specified in section 60.38e of the subpart Ce EG, as amended on October 6, 2009. Sources 

covered under the State Plan would need to maintain thorough records documenting the results 

of their initial and annual performance tests, records of continuous monitoring of their sitespecific operating parameters, records of initial and annual inspections, records of compliance 

with the operator training and qualification requirements, and records of compliance with the 

waste management plan. [40 CFR 60.35e, 60.38e(a) and (b), 60.55c, and 60.58c(b)(2), (b)(6), 

(b)(9), and (b)(10)] Sources would need to keep these records on file for at least 5 years. [40 

CFR 60.58c(b)] 

 The subpart Ce EG provide for owners or operators to submit the results of the initial 

performance test and all subsequent performance tests or inspections. [40 CFR 60.38e(a) and (b) 

and 60.58c(c)(1) and (d)(6) and (d)(9)] Additionally, reports on emission rates or operating 

parameters that have not been obtained or that exceed applicable limits are to be submitted on a 

semi-annual basis. [40 CFR 60.38e(a) and 60.58c(e)] If no exceedences occur during a semiannual period, the owner of the designated facility is to submit an annual report stating that no 

exceedences occurred. [40 CFR 60.38e(a) and (b)(2) and 60.58c(d)] All reports are to be signed 

by the facilities manager. [40 CFR 60.38e(b)(2) and 60.58c(d) and (e)] 

3.5.4 Operator Training and Qualification Requirements

As specified in section 60.34e of the amended subpart Ce EG, State Plans are to require 

that each facility have at least one trained and qualified operator on duty or on-call. The trained 

and qualified HMIWI operator needs to pass an HMIWI operator training course, which is stateapproved or meets the requirements specified in the amended Guidelines. [40 CFR 60.34e and 

3-11 
60.53c(b) and (c)] Also, State Plans are to require each facility to develop site-specific 

information regarding HMIWI operation. [40 CFR 60.34e and 60.53c(h)] State Plans are to 

require each employee involved with the operation of the HMIWI to review the operating 

information developed for the HMIWI each year. [40 CFR 60.34e and 60.53c(i)] 

For designated facilities as defined in section 60.32e(a)(1) of the amended subpart Ce 

(existing sources under the September 15, 1997 HMIWI rule), the initial operator training 

requirements should have been met 1 year after the effective date of either the State Plan 

approval or Federal Plan promulgation. [40 CFR 60.34e and 60.39e(e)] For designated facilities 

as defined in section 60.32e(a)(2) of the amended subpart Ce (NSPS sources under the 

September 15, 1997 HMIWI rule), the initial operator training requirements should have been 

met at the time of initial facility start-up. [40 CFR 60.53c] 

3.5.5 Waste Management Plan Requirements

Section 60.35e of subpart Ce directs State Plans to ensure that facilities develop a waste 

management plan that identifies the feasibility and the approach to separate certain components 

of the solid waste stream from the health care waste stream. The waste management plan 

requirements in State Plans are to be at least as protective as the requirements for waste 

management plans under section 60.55c of subpart Ec. 

For those HMIWI covered under the September 15, 1997 HMIWI rules (subparts Ce and 

Ec), the waste management plan provisions under those rules should have been met no later than 

60 days after the required initial performance test. [62 FR 48381 and 48389] A revised waste 

management plan for those sources, under the amended October 6, 2009 subpart Ce provisions, 

needs to be completed. The revised plan needs to be submitted no later than 60 days after the 

initial performance test demonstrating compliance with the amended subpart Ce emission limits 

contained in an approved, revised or new State Plan. [40 CFR 60.38e(a) and 60.58c(c)(3)] 

3.5.6 Inspection Requirements

Revised or new State Plans are to require facilities to conduct initial and annual HMIWI 

and control equipment inspections. Section 60.36e of the amended subpart Ce lists the 

components of the HMIWI and control equipment which revised or new State Plans are to 

require facilities to inspect. Revised or new State Plans are to require initial HMIWI and control 

equipment inspections for large, medium, and small HMIWI and initial control equipment 

3-12 
inspections, if applicable, for small rural HMIWI within 1 year following EPA approval of the 

revised or new State Plan. [40 CFR 60.36e(a) and (c)] Revised or new State Plans are also to 

require annual HMIWI and control equipment inspections for all existing HMIWI after that 

point. [40 CFR 60.36e(b) and (d)] (Note: Existing small rural HMIWI should have already 

conducted the initial HMIWI equipment inspection included in the 1997 EG for those sources.) 

According to section 60.36e(a)(2) and (c)(2) of the amended subpart Ce, State Plans are to 

require facilities to complete any necessary HMIWI and control equipment repairs within 10 

operating days following an inspection. Revised or new State Plans may allow repairs to be 

completed after 10 operating days, provided that the state supplies the facility with written 

permission and a date by which all repairs are to be completed. [40 CFR 60.36e(a)(2) and (c)(2)] 

3.6 Compliance Schedules

To comply with the emission limits contained in the revised or new section 111(d)/129 

State Plan, existing HMIWI may need to retrofit emission controls. The revised or new State 

Plan needs to contain expeditious schedules for retrofitting these HMIWI. [CAA section 

129(f)(2) and 40 CFR 60.24(a), (c), and (e)(1) and 60.39e(a)-(d)] The elements included in a 

compliance schedule are listed in Table 3-2. 

Table 3-2. Schedule for HMIWI Compliance with the HMIWI 

Emission Guidelines

Activity Date 

State Plan submittal October 6, 2010 

State Plan approval April 6, 2011 

If not in compliance by this date, need 

enforceable increments of progress for 

HMIWI 

April 6, 2012 

Submit a final control plan October 6, 2012a

Award contracts for control system May 6, 2013a

Initiate construction or installation of control 

system 

January 6, 2014a

Complete construction or installation of 

control system 

August 6, 2014a

Final compliance date for HMIWI No later than 3 years from approval of State 

Planb or October 6, 2014, whichever is earlier, or 

3-13 
Activity Date 

shut down by that date 

Reports of periodic performance test data Annually after compliance date, if in compliance; 

semiannually after compliance date, if the 

emission limits or operating parameters are 

exceeded 

a The dates presented for increments of progress are suggested dates based on the schedule 

included in section 62.14470 of the original HMIWI Federal Plan. A specific State Plan could 

include different dates. 

b

 Section 129 does not preclude a state from requiring earlier compliance dates. 

The retrofit schedules for HMIWI are developed by the state air pollution control agency 

considering input from the public and input from the HMIWI owners and operators. The EG 

place certain restrictions on retrofit schedules. Retrofit schedules can extend up to 3 years after 

section 111(d)/129 State Plan approval, but no retrofit schedule can extend beyond October 6, 

2014. [CAA section 129(b)(2) and (f)(2) and 40 CFR 60.39e(c)] 

The section 111(d)/129 State Plan also needs to specify legally enforceable increments of 

progress toward compliance for HMIWI that have compliance or retrofit schedules that extend 

past 1 year beyond approval of the section 111(d)/129 State Plan. [40 CFR 60.24(e)(1) and 

60.39e(c)] In some cases, for example, an HMIWI could shut down as of October 6, 2014 or 

3 years after state approval, whichever is earlier, complete a retrofit, and then reopen when 

retrofits are completed, based on provisions in the original HMIWI Federal Plan. [40 CFR 

62.14472] 

3.6.1 Retrofit Required

The subpart Ce Guidelines are “performance standards,” that is, the standards do not 

prescribe one control system over another, but, rather, the HMIWI owners and operators can 

choose the actual equipment selected for retrofit at a facility that they believe will achieve the 

emission limits. 

Control systems for the regulated HMIWI pollutants can be considered as two subgroups: (1) combustion system upgrades -- referred to as “good combustion” (defined 

previously as 2-second residence time in the secondary chamber at 1800°F); and (2) add-on 

control systems (e.g., wet scrubber, dry injection followed by a fabric filter [DIFF]). “Good 

combustion” controls PM, CO, and organic emissions (e.g., dioxins/furans). Wet scrubbers and 

3-14 
DIFF are more expensive control systems and control multiple pollutants, including 

dioxins/furans, Pb, Cd, Hg, PM, HCl, and SO2. Other add-on control systems that can be used in 

addition to these systems include activated carbon injection systems, which control Hg and 

dioxins/furans, and selective noncatalytic reduction (SNCR) systems, which control NOX. 

The amended EG are based on emission data associated with the best-performing 

12 percent of HMIWI in each HMIWI subcategory (i.e., large, medium, small, small rural units). 

[73 FR 72980] The emission data reflect both technology factors (e.g., add-on control systems) 

and non-technology factors (e.g., waste segregation, good combustion). [73 FR 72964, 72970] 

The best-performing HMIWI use good combustion in combination with various types of add-on 

control systems, except for small rural units, which use good combustion alone (i.e., no add-on 

control systems in place). [73 FR 72980] HMIWI also use waste segregation. [73 FR 72964, 

72975, 72979] 

3.6.2 Retrofit Schedules for HMIWI

 Under section 60.39e(c) of subpart Ce, HMIWI retrofits are to be in compliance with the 

amended EG within 3 years after approval of the revised or new State Plan or by October 6, 

2014, whichever is earlier. Note, however, that enforceable increments of progress are required 

for units with compliance schedules extending more than 1 year after State Plan approval. [40 

CFR 60.24(e)(1) and 60.39e(c)] As noted previously, State Plans could allow units to shut down 

by the specified date and restart after completing the retrofit. [40 CFR 60.24(e)(1) and 60.39e(c); 

see also 40 CFR 62.14472 of the original HMIWI Federal Plan as an example] 

3.6.3 Increments of Progress

Compliance schedules for HMIWI with compliance dates that extend more than 1 year 

after State Plan approval should include legally enforceable increments of progress towards 

compliance as required by section 60.24(e) of subpart B. Each increment of progress from 

section 60.21(h) of subpart B should have an enforceable compliance date in the revised or new 

section 111(d)/129 State Plan. The minimum five increments of progress required by 

section 60.21(h) of subpart B for each HMIWI within a state are as follows: 

3-15 
1. Submitting a final control plan. This may be a brief document or letter describing 

the controls that the source will use to comply with the emission limits and other 

requirements. In most cases, the source, public, and state will have discussed this 

information as part of the state process for development of the compliance 

schedule for the draft State Plan before the State Plan is submitted to EPA; [40 

CFR 60.21(h)(1)] 

2. Awarding contracts for control systems or process modifications or orders for 

purchase of components; [40 CFR 60.21(h)(2)] 

3. Initiating on-site construction or installation of the air pollution control device(s) 

or process changes; [40 CFR 60.21(h)(3)] 

4. Completing on-site construction or installation of control equipment or process 

changes; [40 CFR 60.21(h)(4)] and 

5. Final compliance. [40 CFR 60.21(h)(5)] 

EPA’s rules allow States a variety of options in setting the dates associated with these 

increments of progress. For example, all five increments of progress for HMIWI could be fixed 

calendar dates or set as floating dates. For increments one to four, the floating dates could be 

tied to either the date of the approval of the revised or new State Plan or the date of a local 

permit issuance. Also, the date for submitting a final control plan could be set as 3 months 

following approval of the State Plan. If an increment of progress is tied to the date of a permit 

issuance, EPA recommends the State Plan should identify the specific permit. 

The fifth increment of progress, the date for final compliance, could also be set as a 

calendar date or a floating date. As a floating date, it should be tied only to the date of the 

approval of the revised or new State Plan, not to the date of permit issuance and would need to 

include the limitation that the date in no case can be later than 3 years from State Plan approval 

or October 6, 2014, whichever is earlier (unless the HMIWI will shut down). [CAA section 

129(b)(2) and (f)(2) and 40 CFR 60.39e(c) and (d)] 

 The State Plan could include additional increments of progress as may be necessary for 

close and effective supervision of progress toward final compliance. Additional suggested 

increments of progress are listed in section 60.39e(c)(1) through (9) of subpart Ce. Some of 

these suggested increments of progress are already required by subpart B. The remaining 

suggested increments of progress could be included in the revised or new section 111(d)/129 

State Plan as enforceable increments of progress with compliance dates, as non-enforceable 

3-16 
increments of progress with reporting requirements only, or they could be left out of the revised 

or new section 111(d)/129 State Plan entirely. 

The additional suggested increments of progress from subpart Ce are: 

1. Date for submitting a petition for site-specific operating parameters; [40 CFR 

60.39e(c)(1)] 

2. Date for obtaining services of an architectural and engineering firm regarding the 

air pollution control device(s); [40 CFR 60.39e(c)(2)] 

3. Date for obtaining design drawings of the air pollution control device(s); [40 CFR 

60.39e(c)(3)] 

4. Date for ordering the air pollution control device(s); [40 CFR 60.39e(c)(4)] 

5. Date for obtaining the major components of the air pollution control device(s); 

[40 CFR 60.39e(c)(5)] 

6. Date for initiation of site preparation for installation of the air pollution control 

device(s); [40 CFR 60.39e(c)(6)] 

7. Date for initiation of installation of the air pollution control device(s); [40 CFR 

60.39e(c)(7)] 

8. Date for initial startup of the air pollution control device(s); [40 CFR 

60.39e(c)(8)] and 

9. Date for initial compliance test(s) of the air pollution control device(s). [40 CFR 

60.39e(c)(9)] 

The revised or new section 111(d)/129 State Plan may include one set of increments with 

compliance dates applicable to all HMIWI within the state or it may tailor compliance dates to 

individual HMIWI to address specific issues. In all cases, the enforceable increments of progress 

should be arranged chronologically, and the compliance dates should be set to ensure full 

compliance with the applicable requirements as expeditiously as practicable [40 CFR 60.24(c)] 

but not later than 3 years after State Plan approval, or October 6, 2014, whichever is earlier. For 

example, a revised or new State Plan that requires a HMIWI to “submit a final control plan and 

to award contracts no later than the third year of the compliance schedule” would likely be 

disapproved because the increments are too close to the end of the compliance window, do not 

appear to ensure expeditious progress, and thus jeopardize timely compliance, unless the HMIWI 

plans to shut down. Although there may be HMIWI-specific reasons for other schedules, EPA 

3-17 
would expect contracts to be awarded within the first year for HMIWI taking longer than 1 year 

to comply. Depending on the extent of the retrofit, EPA would expect on-site construction to be 

completed in the second or third year of the compliance schedule. 

3.6.4 HMIWI Shutdowns

Hospital/medical/infectious waste incinerators that are planning to shut down rather than 

meet the amended EG should be identified in the revised or new State Plan. [40 CFR 60.25(a)] 

These State Plans should specify that HMIWI planning to comply by shutting down should do so 

by a specific calendar date which is not later than 1 year after State Plan approval. [40 CFR 

60.39e(b); see also 40 CFR 62.14471 of the original HMIWI Federal Plan as an example] As 

discussed in section 3.3, HMIWI which shut down should be included in the state’s source 

inventory unless the HMIWI is rendered inoperable. [40 CFR 60.25(a); see 65 FR 49876 in the 

preamble to the original HMIWI Federal Plan as an example] In some special cases, facilities 

may be allowed more than 1 year after State Plan approval to shut down, provided that the State 

Plan contains provisions for allowing facilities to petition the state for an extension. Section 

60.39e(d) of subpart Ce outlines the specific provisions that State Plans should include in order 

to allow facilities more than 1 year to shut down. 

The provisions of section 60.39e(d) allow states to provide temporary relief to those 

unique facilities which are planning to shut down and have no waste disposal options other than 

onsite incineration. One example of a facility planning to shut down which has special needs for 

an extension beyond the 1-year compliance deadline would be a facility planning to install an 

onsite alternative waste treatment technology (e.g., an autoclave) that will not be available for 

installation until after the 1-year deadline. Such a facility would need to be able to demonstrate 

that there are no waste disposal options (e.g., commercial disposal) other than onsite incineration 

in the interim while the autoclave is being installed. [40 CFR 60.39e(d)(1)(i)] A second example 

of a facility planning to shut down that may need an extension beyond the 1-year deadline would 

be a facility planning to contract with a commercial hauler that, for some unusual reason, is 

unable to secure a contract by the 1-year deadline. [40 CFR 60.39e(d)(1)(i)] 

Under such special circumstances, states could allow facilities to petition the state after 

approval of a State Plan for additional time to come into compliance by shutting down their 

HMIWI. In order to allow facilities an extension, the State Plan would need to contain 

provisions for granting or denying petitions for an extension beyond the 1-year deadline. 

3-18 
Section 60.39e(d) of subpart Ce directs that states have sources submit the following information 

in time to allow the state adequate opportunity to grant or deny the extension before the 1-year 

compliance deadline: 

1. Documentation of the analysis undertaken to support the need for an extension, 

including an explanation of why up to 3 years after EPA approval of the Sate Plan 

is sufficient while 1 year after EPA approval the State Plan is not sufficient; 

2. An evaluation of the option to transport the waste offsite to a commercial medical 

waste treatment and disposal facility on a temporary or permanent basis; and 

3. A plan that documents measurable and enforceable incremental steps of progress4

to be taken towards compliance with the EG. 

When a petition for an extension is granted, states could allow sources planning to shut 

down up to 3 years after EPA approval of the revised or new State Plan to come into compliance 

with the amended EG by shutting down. [40 CFR 60.39e(d)(3)] However, states should use their 

best judgment to determine if the source can shut down before the date 3 years after EPA 

approval of the revised or new State Plan. In cases where a source requesting an extension is 

able to shut down before the 3-year deadline, the state should require the source to shut down as 

soon after the 1-year compliance deadline as possible. [CAA section 129(f)(2) and 40 CFR 

60.24(c) and 60.39e(d)(3)] 

Commercial medical waste disposal services, which collect medical waste from a facility 

and transport it to a central disposal site (usually a commercial HMIWI), are operated in many 

areas of the country. In some locations commercial disposal services are not readily available at 

a reasonable cost because the hauler would need to travel long distances. However, in many 

cases, the services of a commercial medical waste disposal company are available and can be 

acquired in a short period of time. Sources installing an onsite alternative waste treatment 

technology, in most cases, could contract with a commercial disposal company in the interim 

period between the 1-year compliance deadline and the time when the onsite alternative is 

installed. Therefore, section 60.39e(d) requires State Plans including provisions for an extension 

 4 The incremental steps of progress for units planning to shut down are not the same as 

the incremental steps of progress for facilities planning to retrofit their HMIWI and continue 

operation. The increments of progress for facilities planning to shut down are intended to 

demonstrate that the facility is in the process of shutting down. Specific increments are 

discussed later in this section. 

3-19 
to have the source requesting an extension document reasons why the services of a commercial 

disposal company cannot be reasonably obtained. 

Sources planning to shut down which request an extension are also to provide the state 

with a plan that documents the incremental steps of progress that the facility intends to take to 

demonstrate that it is in the process of shutting down. [40 CFR 60.39e(d)(1)] The source plan 

should contain completion dates for each of the increments of progress contained in the plan. 

The following are some suggested increments of progress (based on the original HMIWI Federal 

Plan) that sources requesting extensions to install onsite alternative treatment technologies could 

use to demonstrate to the state that they are in the process of shutting down their HMIWI: 

1. Going under contract with an alternative treatment technology vendor; 

2. Initiating onsite construction or installation of the alternative treatment 

technology; 

3. Completing onsite construction or installation of the alternative treatment 

technology; 

4. Shutting down the existing HMIWI; and 

5. Rendering the existing HMIWI inoperable.5

[40 CFR 62.14471(b)(1)(ii); 65 FR 49876] 

The following are some suggested increments of progress (based on the original HMIWI 

Federal Plan) that sources requesting extensions to contract with a commercial disposal company 

on a permanent basis could use to demonstrate to the state that they are in the process of shutting 

down their HMIWI: 

1. Obtaining price quotes from commercial disposal services; 

2. Going under contract with a commercial waste treatment and disposal facility; 

3. Shutting down the existing HMIWI; and 

4. Rendering the existing HMIWI inoperable.3 

[40 CFR 62.14471(b)(1)(ii); 65 FR 49876] 

3.7 Public Hearings

Public participation, under the provisions of the CAA, is an important right and 

responsibility of citizens in the state process of developing, adopting, and implementing 

section 111(d)/129 State Plans. As with SIPs for criteria pollutants, EPA regulations in 40 CFR 

Part 60, subpart B, make it clear that citizen input on section 111(d)/129 State Plans is 

 5 Rendering the HMIWI inoperable is not necessary for a source to be shut down; 

however, any HMIWI capable of operation should be included on the state’s source inventory 

(see section 3.3). [40 CFR 60.25(a)] 

3-20 
encouraged in order to help define appropriate emission standards and retrofit schedules. Under 

section 60.23 of subpart B, some minimum public participation requirements are as follows: 

1. Reasonable notice of opportunity for one or more public hearing(s) at least 30 

days before the hearing(s). [40 CFR 60.23(d)] 

2. One or more public hearing(s) on the section 111(d)/129 State Plan (or revision) 

conducted at location(s) within the state, if requested. [40 CFR 60.23(c)(1)] 

3. Date, time, and place of hearing(s) prominently advertised in each region affected. 

[40 CFR 60.23(d)(1)] 

4. Availability of draft section 111(d)/129 State Plan for public inspection in at least 

one location in each region to which it will apply. [40CFR 60.23(d)(2)] 

5. Notice of hearing provided to: 

a. EPA Regional Administrator 

b. Local affected agencies 

c. Other states affected 

[40 CFR 60.23(d)(3)-(5)] 

6. Certification that the public hearing was conducted in accordance with subpart B 

and state procedures. [40 CFR 60.23(f)] Upon written application by the state 

agency, EPA may (for limited special cases) approve different procedures, 

provided that they ensure adequate public participation. [40 CFR 60.23(g)] 

7. Retention of hearing records (e.g., list of commenters, their affiliation, and a 

summary of each presentation and/or comments submitted) for a minimum of 

2 years. [40 CFR 60.23(e)] 

3.8 State Progress Reports to EPA

In their revised or new section 111(d)/129 State Plans, states are to commit to send EPA 

annual reports on progress in the implementation of the amended EG. [40 CFR 60.25(e)] These 

reports can be incorporated into the annual source emissions and State action report required by 

40 CFR section 51.321. Inclusion in this SIP report is intended to avoid duplicative reports. 

Each progress report should include compliance status, enforcement actions, increments of 

progress, identification of sources that have shut down or started operation, emission inventory 

information for sources that have started operation, updated emission inventory and compliance 

information, and copies of technical reports on all performance testing and monitoring, including 

concurrent process data. [40 CFR 60.25(f)(1)-(6)] 

3-21 
3-22 

States may want to include additional information in their progress reports, such as 

periodic inspection and testing activities, emission and parameter exceedances, quality 

assurance/quality control (QA/QC), outreach activities, title V or other permit condition 

compliance status, and compliance assistance activities. 

Some states and EPA Regional Offices have developed more specific or tailored 

reporting and recordkeeping procedures via Memoranda of Agreements, Program Specific 

Guidance for section 105 Grants, and the Timely and Appropriateness Guidance. For example, 

some EPA Regional Offices prefer that the states retain the performance test reports until EPA 

requests review as part of a compliance determination or other action. The state and EPA will 

continue to have discretion on the format of the annual reports. 
4.0  Requirements for Co­fired Combustors and Incinerators

Burning Only Pathological, Low­level Radioactive, and

Chemotherapeutic Waste

Co-fired combustors are defined as units combusting 10 percent by weight or less 

hospital waste and/or medical/infectious waste with other fuels or wastes (e.g., coal, municipal 

solid waste). [40 CFR 60.51c] The original 1997 EG exempted co-fired combustors and 

incinerators burning only pathological, low-level radioactive, and chemotherapeutic waste from 

most of the requirements under the EG. [62 FR 48380, 40 CFR 60.32e(b) and (c)] These 

exemptions were not changed in the 2009 amended EG. All revised/updated or new State Plans 

are to require these units to notify the Administrator of an exemption claim and to keep certain 

records, per section 60.32e(b)(1) and (2) (pathological, low-level radioactive, and 

chemotherapeutic) and section 60.32e(c)(1)-(3) (co-fired) of the HMIWI rule, if not already done 

so in response to the 1997 guidelines. 

Assuming an approved State Plan is in effect, exemption claims are to be sent to the head 

of the state air pollution control agency responsible for implementing the EG through the State 

Plan, with a courtesy copy of the exemption claim sent to the appropriate EPA Regional Office. 

[40 CFR 60.26(a), 60.32e(b)(1) and (c)(1), and 62.10] A list of state and Regional Office 

contacts is provided in Appendix E. Exemption claims are to be received by the state agency and 

EPA Regional Office within 1 year following State Plan approval, providing adequate time for 

the state to determine if an exemption is in order. [40 CFR 60.39e(b)] 

Facilities operating co-fired combustors are to provide the state with an estimate of 

(1) the amount of hospital and medical/infectious waste combusted, and (2) the amount of other 

fuels and wastes being combusted. [40 CFR 60.32e(c)(2)] This information could be submitted 

to the state as part of the exemption claim. In addition to submitting an exemption claim, 

facilities operating co-fired combustors are to keep records on a calendar quarter basis on the 

weight of hospital waste and medical/infectious waste combusted and the weight of all other 

fuels and/or wastes combusted. [40 CFR 60.32e(c)(3)] The EG do not direct states to have 

facilities operating co-fired combustors maintain records of each individual type of waste 

burned. Rather, the EG should be interpreted, as in the original HMIWI Federal Plan, to mean 

that facilities are to keep records of two categories of wastes: (1) the combined weight of hospital 

waste and medical/infectious waste, and (2) the combined weight of all other wastes and fuels 

4-1 
4-2 

burned at the co-fired incinerator. [40 CFR 62.14400(b) and 65 FR 49872, 49882] 

Incinerators are not subject to the emission standards of subpart Ce during periods when 

only pathological, low-level radioactive, and/or chemotherapeutic waste are being incinerated, 

provided the facility submits an exemption claim and keeps records on a calendar quarter basis 

of periods of time when only such waste is burned. [40 CFR 60.32e(b)(1) and 2)] 

As discussed in section 3.3, under the section 111(d)/129 State Plan requirements, states 

are to include co-fired combustors and incinerators burning only pathological, low-level 

radioactive and/or chemotherapeutic waste in their source inventory. [40 CFR 60.25(a) and 

60.32e(b) and (c)] 
5.0  Title V Requirements for HMIWI

Title V of the CAA provides for a nationwide operating permit program which applies to 

all major sources and to certain other sources. The title V permit brings together in one 

document all of the CAA requirements that apply to a source. Title V permits clarify which 

requirements apply to each source and describe how compliance with those requirements is to be 

maintained and demonstrated. All of the regulations applicable to each HMIWI are ultimately 

incorporated into the title V permit for the affected source. 

State air quality agencies implement the operating permit program pursuant to criteria in 

40 CFR Part 70. EPA implements the title V program under 40 CFR Part 71 in Indian country 

until Tribes gain approval of their permitting program. 

5.1 Existing HMIWI

Owners and operators of all existing HMIWI should have already submitted permit 

applications and been issued a title V permit as a result of the original EG issued in 1997. With 

the 2009 revision of the EG, states are to develop and seek EPA approval for revised or new 

State Plans, and EPA is to promulgate a new Federal Plan for states that do not have an approved 

State Plan. If 3 or more years are remaining on the permit term for an HMIWI when the 

applicable State Plan is approved and becomes effective or the Federal Plan is promulgated and 

becomes effective, then the HMIWI owner and/or operator will receive from its permitting 

authority a notice of intent to reopen the title V permit to include the new requirements of the 

applicable State/Federal Plan. [40 CFR 70.7(f)(1)(i) and 65 FR 49868, 49878, August 15, 2000] 

If less than 3 years are remaining on the permit term at the time the applicable State Plan or 

Federal Plan becomes effective, then the owner and/or operator need not modify its title V permit 

to include the applicable requirements until permit renewal--bearing in mind that the sources are 

subject to the applicable State/Federal Plan requirements, even though the requirements are not 

yet contained in the permit. [40 CFR 70.7(f)(1)(i), 71.7(f)(1)(i), and 65 FR 49868, 49878, 

August 15, 2000] Owners and operators are reminded that they need to wait until the revised or 

new State Plan has been approved and becomes effective or the new Federal Plan has been 

promulgated and becomes effective before they can determine how much time remains on their 

permit term. [65 FR 49868, 49878, August 15, 2000] 

5-1 
5-2 

5.2 Exempt Units

Co-fired combustors and incinerators burning only pathological, low-level radioactive, 

and chemotherapeutic waste are exempt from the HMIWI emission limits, so the owners and 

operators of those sources are not required to obtain a title V permit under the HMIWI 

regulation.1 [CAA section 502(a), 40 CFR 70.3(a)(2), 71.3(a)(2), and 62.14480, and 65 FR 

49868, 49872] If the incinerators burn waste other than pathological, low-level radioactive, or 

chemotherapeutic waste, then the incinerators are subject to the EG and are also subject to the 

requirement to apply for a title V permit. Additionally, if the incinerators or co-fired combustors 

do not comply with the recordkeeping and notification requirements necessary to qualify for 

exemption from the other requirements of the EG, these sources then become subject to the other 

requirements of the EG and also to the requirement to obtain a title V permit. [40 CFR 

60.32e(b)(1) and (2), 60.32e(c)(1)-(3), and 65 FR 49868, 49878, August 15, 2000] 

 1 However, this does not necessarily mean they would not be required to obtain a title V 

permit under a different regulation (e.g., the OSWI regulation). 

Appendix A 

Key Elements of an Acceptable Section 111(d)/129 State Plan for HMIWI
A-1 

 APPENDIX A--KEY ELEMENTS FOR AN ACCEPTABLE SECTION 111(d)/129 

STATE PLAN FOR HMIWI 

This document is provided to facilitate preparation of the required revised/amended or 

new State Plans.

Section 129 of the Clean Air Act (Act) requires that states submit to the U.S. 

Environmental Protection Agency (EPA) State Plans to implement and enforce the Emission 

Guidelines (EG) promulgated for hospital/medical/infectious waste incinerator(s) (HMIWI) 

pursuant to sections 111(d) and 129 of the Act. Section 129 requires that the state submit the 

State Plans not later than one year after EPA promulgates the EG. On September 15, 1997, EPA 

promulgated the EG as 40 CFR Part 60, subpart Ce, and State Plans were submitted to EPA for 

approval no later than one year later. A court remand necessitated revisions to the 1997 rule, and 

on October 6, 2009, EPA promulgated amendments to the rule. Revised/amended or new State 

Plans implementing the amended EG are due no later than October 6, 2010. 

The official procedures for adoption and submittal of State Plans are codified in 40 CFR 

Part 60, subpart B. The EPA promulgated the subpart B provisions on November 17, 1975. The 

EPA amended them on December 19, 1995, to allow the subparts developed under section 129 to 

include specifications that supersede the provisions in subpart B regarding the schedule for 

submittal of State Plans, the stringency of the emission limitations, and the compliance 

schedules. That is, these amendments were promulgated in order to allow conformity with 

section 129, which requires the State Plans for HMIWI be submitted within one year and 

requires the State Plans to be as protective as the EG and requires that each unit be in compliance 

not later than three years after the State Plan is approved by EPA and no later than five years 

after the EG is promulgated (rather than the case-by-case exceptions the state may demonstrate 

as otherwise specified in subpart B). 

States must adopt their State Plans according to state procedures prior to official 

submittal to EPA. [section 60.23 (a)] At a minimum, the revised/amended or new State Plan 

must include the following elements: 

• A demonstration of the state’s legal authority to carry out the revised/amended or 

new section 111(d)/129 State Plan as submitted; 

• Demonstration of approval of state’s legal authority by Administrator; 

• An inventory of HMIWI in the state affected by the amended Emission 

Guidelines; 

• An inventory of emissions from HMIWI in the state; 

• Emission limits at least as protective as the amended emission limits in 

subpart Ce; 
A-2 

• Testing and monitoring requirements at least as protective as the amended testing 

and monitoring requirements in subpart Ce; 

• Recordkeeping and reporting requirements at least as protective as the amended 

recordkeeping and reporting requirements in subpart Ce; 

• Inspection requirements at least as protective as the amended inspection 

requirements in subpart Ce; 

• Operator training and qualification requirements at least as protective as the 

operator training and qualification requirements in subpart Ce; 

• Waste management plan requirements at least as protective as the amended waste 

management plan in subpart Ce; 

• Compliance schedules, extending no later than October 6, 2014; 

• A final compliance date no later than October 6, 2014; 

• A record of public hearing(s) on the revised/amended or new State Plan; and 

• Provision for annual state progress reports to EPA on implementation of the 

revised/amended or new State Plan; 

The following pages include information about legal authority, emission inventories, 

emission standards and other emission limitations, source surveillance, compliance assurance, 

enforcement, compliance schedules, and cross-references to the EG. 

A. Legal Authority [section 60.26(a)]

1. The State Plan shall include demonstration of the state’s legal authority to: 

(a) adopt emission standards (enforceable conditions) and compliance 

schedules applicable to the designated facilities and designated pollutants 

for which the State Plan is submitted; 

(b) enforce applicable laws, regulations, standards, and compliance schedules, 

and seek injunctive relief; 

(c) obtain information necessary to determine compliance; 

(d) require recordkeeping, make inspections, and conduct tests; 

(e) require the use of monitors and require emission reports of owners or 

operators; and 
A-3 

(f) make emission data publicly available.

2. The state must specifically identify the provisions above and include copies of the 

provisions of the law establishing such legal authority unless they have been 

approved as a portion of a previous State Implementation Plan (SIP). To facilitate 

its review of State Plans, EPA encourages states to submit an opinion by the 

state’s Attorney General as part of the demonstration required above. States may 

use previously submitted Attorney General opinions (e.g., under title V) to the 

extent those documents specifically address the requirements of section 60.26 as 

they apply to the designated facilities and the designated pollutants. [section 

60.26(b)]

3. The legal authority shown must be in effect at time of State Plan submission. 

[section 60.26(c)]

4. The state may authorize another state governmental agency to carry out a portion 

of the State Plan, provided the state demonstrates that the state governmental 

agency has adequate authority. [section 60.26(e)]

5. The state may authorize a local agency to carry out a portion of the State Plan 

provided that the state demonstrates that the local agency has adequate legal 

authority to implement that portion of the State Plan and the state is not relieved 

of responsibility. [section 60.26(e)]

B. Emission Inventories

The State Plan must include an “emission inventory” of all designated pollutants for all 

designated facilities. [section 60.25(a)]

Emission data must be included where available, but estimates can be used where data 

are not currently available. Emission factors and default values are described in this Summary 

Document. 

In addition to the initial inventory, updates are required. [section 60.25(f)(5] The 

updated information is required to be submitted annually in the section 51.321 reports. [section 

60.24(e)(1)] The emission data should be submitted to the Air Facility System (AFS) [sections 

51.321-51.323]

C. Emission Standards and other Emission Limitations

1. The emission limitations must be at least as protective as the EG. If the 

limitations are not identical, the state must demonstrate that the standards are at 

least as protective. [section 60.24(f), as revised December 19, 1995, to be 

consistent with section 129 of the Act and section 60.33e of subpart Ce]

NOTE: Nothing in the Clean Air Act nor the CFR restricts the state from having standards and 

schedules more stringent than the EG. [section 60.24(g)]
A-4 

2. The State Plan shall include the specific emission limitations, preferably crossreferenced to the specific EG requirements. [section 60.24(a)]

3. Test methods and procedures for determining compliance shall be specified. 

[section 60.24(b)2)]

4. If the methods and procedures are not identical to those in section 60.56c, the 

state must demonstrate equivalence or request EPA approval of acceptable 

alternatives per current EPA method review procedures. [section 60.24(b)(2)]

5. If emission standards are adopted by local agencies or other state agencies, they 

must also be included in the State Plan and if not identical to the EG, then the 

state must show that they are at least as protective as the emission guidelines. 

[section 60.24(a)]

D. Source Surveillance, Compliance Assurance & Enforcement

The State Plan must provide for monitoring the status of compliance. As a minimum, the 

State Plan shall include: 

1. Provisions for legally enforceable procedures to: 

(a) require recordkeeping on nature and amount of emissions and reports to 

the state. [section 60.25(b)(1)]

(b) require any additional information to judge compliance. [section 

60.25(b)(1)]

2. Provisions for periodic inspection and testing, if necessary. [section 60.25(b)(2)]

3. Provisions for emission data and other compliance monitoring information to be 

correlated with applicable emission standards and be made available to the public. 

“Correlated” means showing the relationship between the measured or estimated 

amounts of emissions and the amounts of such emissions allowable. For example, 

the emissions should be in the same units and averaging times. [section 60.25(a) 

and (c)]

4. HMIWI requirements for testing, monitoring, recordkeeping, and reporting that 

are identical to those specified in sections 60.37e and 60.38e. [subpart Ce]

5. Specific identification of the provisions in 1 through 4 above. Copies of such 

provisions should be included unless they have been approved as portions of a 

preceding section 111(d)/129 State Plan or SIP and the state demonstrates that the 

provisions are applicable and the requirements of section 60.26 (legal authorities) 

are met. [section 60.25(d)] 
A-5 

6. Commitment to submit reports on progress in plan enforcement to the EPA 

Regional Administrator on an annual basis and include it in the reports required 

by 51.321. [section 60.25(e) and (f)] Each progress report shall include: 

enforcement actions, achievement of increments of progress, identification of 

sources that have ceased operation, emission inventory information for sources 

that were not in operation at the time of plan development, updated emission 

inventory and compliance information, and copies of technical reports on all 

performance testing, including concurrent process data. [section 60.25(f)(1) 

through 60.25(f)(6)] 

Note: Some states and Regions have developed more specific or tailored reporting and 

recordkeeping procedures via Memoranda of Agreements, Program Specific Guidance for 

Section 105 Grants, and the Timely and Appropriateness Guidance that should also be followed. 

For example, some Regions prefer that the state retain the performance test report until the 

Region needs to review it as part of a compliance determination or other action.

E. Compliance Schedules

1. Compliance schedules must match the subpart Ce and B specifications. 

[subpart Ce, section 60.39e]

2. For compliance schedules extending more than 12 months beyond the date of 

EPA approval of the State Plan, the compliance schedule must include legally 

enforceable increments of progress towards compliance for that HMIWI. Each 

increment of progress in section 60.21(h) of subpart B must have a compliance 

date and must be included as an enforceable increment in the State Plan. The 

State Plan may include such additional increments of progress as may be 

necessary to permit close and effective supervision of progress towards final 

compliance. [sections 60.24(e)(1), 60.21(h), & 60.39e] 

The minimum five increments of progress are as follows: 

(a) Submitting a final control plan (This may be a brief document or letter 

describing the controls that the source will use to comply with the 

emission limitations and other requirements. In most cases, the source, 

public, and state will have discussed this information as part of the state 

process for development of the compliance schedule for the draft State 

Plan prior to submittal of the State Plan to EPA.); [section 60.21(h)(1)]

(b) Awarding contracts for control systems or process modifications or orders 

for purchase of components; [section 60.21(h)(2)]

(c) Initiating on-site construction or installation of the air pollution control 

device(s) or process changes; [section 60.21(h)(3)]

(d) Completing on-site construction or installation of control equipment or 

process changes; [section 60.21(h)(4)]
A-6 

(e) Final compliance. [section 60.21(h)(5)]

The first four of these increments of progress can be set as calendar dates or floating 

dates tied to the date of the approval of the revised/amended or new State Plan or the issuance 

date of a local permit issuance. For example, the date for submitting a final control plan could 

be set as three months following approval of the State Plan. If an increment of progress is tied to 

the date of a permit issuance, the State Plan must identify the specific permit. 

The fifth increment of progress, the date for final compliance, can be set as a calendar 

date or a floating date, but if it is floating, it can be tied only to the date of approval of the 

revised/amended or new State Plan, not the date of permit issuance, and must include the 

limitation that the date can in no case be later than three years from State Plan approval or 

October 6, 2014, whichever is earlier (unless the HMIWI will shut down). 

3. Suggested measurable and enforceable activities are listed in section 60.39e(c)(1) 

through (9) (60 FR 48381). The state may choose to include them in the 

revised/amended or new State Plan as enforceable increments of progress with 

compliance dates, or as non-enforceable increments of progress with reporting 

requirements only, or choose to leave them out of the revised/amended or new 

State Plan. 

The suggested increments of progress activities are: 

(a) Date for submitting a petition for site-specific operating parameters; 

(b) Date for obtaining services of an architectural and engineering firm 

regarding the air pollution control device(s); 

(c) Date for obtaining design drawings of the air pollution control device(s); 

(d) Date for ordering the air pollution control device(s) [already required 

where practicable by sections 60.24(e)(1) and 60.21(h)(1)]; 

(e) Date for obtaining the major components of the air pollution control 

device(s); 

(f) Date for initiation of site preparation for installation of the air pollution 

control device(s) [already required where practicable by sections 

60.24(e)(1) and 60.21(h)(1)]; 

(g) Date for initiation of installation of the air pollution control device(s); 

(h) Date for initial startup of the air pollution control device(s); 

(i) Date for initial compliance test(s) of the air pollution control device(s); 
A-7 

The EPA strongly recommends that activities (h) and (i) be included in the compliance 

schedules. Performance tests must be conducted within 180 days after the final retrofit, and the 

report of the test results must be submitted within 60 days after the test is conducted. The test 

results will demonstrate whether or not the HMIWI is in compliance with the emission 

standards. This performance test timing is consistent with other EPA air regulations for existing 

sources, such as the Part 63 General Provisions for national emission standards for hazardous air 

pollutants (NESHAP). The EPA also strongly encourages states and HMIWI owners or 

operators to conduct preliminary performance tests at least 2-3 months prior to the scheduled 

final compliance date, in order for the HMIWI to make any necessary shakedown changes and 

retest(s), as necessary, prior to the final compliance date. 

4. The State Plan may include one set of increments with compliance dates 

applicable to all HMIWI within the state, or it may tailor compliance dates to 

individual HMIWI to address specific issues. In all cases, the enforceable 

increments of progress must be arranged chronologically, and the compliance 

dates must be set to ensure full compliance with the applicable requirements as 

expeditiously as practicable [section 60.24(c)], but not later than three years after 

State Plan approval, or October 6, 2014, whichever is earlier. For example, a 

revised/amended or new State Plan that requires an HMIWI to “submit a final 

control plan and to award contracts no later than the third year of the compliance 

schedule” will likely be disapproved because the increments are too close to the 

end of the compliance window, do not appear to ensure expeditious progress, and 

thus jeopardize timely compliance, unless the HMIWI plan to shut down. 

Although there may be HMIWI-specific reasons for other schedules, EPA would 

expect contracts to be awarded within the first year for HMIWI taking longer than 

one year to comply. Depending on the extent of the retrofit, EPA would expect 

on-site construction to be completed in the second or third year of the compliance 

schedule. 

F. Public Participation 

Public participation, under the Clean Air Act, is an important right and responsibility of 

citizens in the state process of developing, adopting, and implementing the required 

section 111(d)/129 State Plans. Under 40 CFR Part 60, subpart B, the minimum requirements 

for the state to conduct public hearings on the adoption of State Plans and any revisions thereof 

are as follows: 

l. Reasonable notice of one or more public hearing(s) at least 30 days prior to the 

hearing(s). [section 60.23(d)]

2. One or more public hearing(s) on the State Plan (or revisions) conducted in 

location(s) within the state. [section 60.23(c)(1)]

3. Date, time and place of hearing(s) prominently advertised in each region affected. 

[section 60.23(d)(1)] “Region” is defined as “air quality control region.” [section 

60.21(i)]
A-8 

4. Availability of draft State Plan for public inspection in at least one location in 

each region to which it will apply. [section 60.23(d)(2)]

5. Notice of hearing provided to: (a) EPA Regional Administrator, (b) local affected 

agencies, and (c) other states affected. [section 60.23(d)(3),(4),&(5)] 

6. Retention of hearing records (e.g., list of commenters and their affiliation and 

summary of each presentation and comments submitted and the state’s responses 

to those comments) for at least 2 years. [section 60.23(e) and (f)]

7. Certification that public participation was conducted in accordance with subpart B 

and state procedures. [section 60.23(f)] Upon written application by the state 

agency, EPA may (expected only for limited special cases) approve different 

procedures provided that they ensure adequate public participation. [section 

60.23(g)] 

No hearing is required on a state or local emission standard in effect prior to October 6, 

2009, the promulgation date of the subpart Ce amendments, if it was adopted after a public 

hearing and is at least as stringent as the emission guideline. [section 60.23(c)(3)] 

Similarly, no public hearing is required for any change to an increment of progress unless 

the change is likely to cause the facility to be unable to comply with the final compliance date. 

[section 60.23(c)(2)]
Appendix B 

Fact Sheet for Amended Emission Guidelines and NSPS 

(40 CFR Part 60 Subparts Ce and Ec)
B-1 

 APPENDIX B-- FACT SHEET FOR AMENDED EMISSION GUIDELINES AND NSPS 

(40 CFR PART 60 SUBPARTS Ce AND Ec) 

Note: An electronic copy of the Fact Sheet for the amended Emission Guidelines and NSPS for 

HMIWI is available at EPA’s TTN Air Toxics Website for HMIWI: 

http://www.epa.gov/ttn/atw/129/hmiwi/rihmiwi.html. 

FACT SHEET 

FINAL AMENDMENTS TO NEW SOURCE PERFORMANCE STANDARDS AND 

EMISSION GUIDELINES FOR HOSPITAL, MEDICAL, AND INFECTIOUS WASTE 

INCINERATORS 

 

ACTION 

 

• On September 15, 2009, the Environmental Protection Agency (EPA) issued final 

revisions to the September 1997 new source performance standards (NSPS) and emission 

guidelines to control emissions from existing hospital, medical, and infectious waste 

incinerators (HMIWI). 

• EPA recalculated the maximum achievable control technology (MACT) floors for 

existing and new HMIWI and developed new emission limits. The MACT floor level of 

control is the minimum level of stringency that can be considered in establishing 

standards under Section 129 of the Clean Air Act. 

• The final emission limits will require improvements in performance for 50 of the 57 

currently operating HMIWI. EPA estimates that a total of 393,000 pounds per year of the 

regulated pollutants will be reduced, of which acid gases (i.e., hydrogen chloride and 

sulfur dioxide) comprise about 62 percent, particulate matter about 0.8 percent, carbon 

monoxide about 0.3 percent, nitrogen oxides about 37 percent, and metals (i.e., lead, 

cadmium, and mercury) and dioxins/furans about 0.2 percent. 

• EPA estimates that the total nationwide cost for the 57 currently operating HMIWI to 

comply with the final rule revisions will be approximately $15.5 million per year. EPA 

also estimates that the cost of an available disposal alternative would be about $10.6 

million, or roughly two-thirds of the estimated compliance costs. 

• Based on the stringency of revisions being promulgated for the NSPS, EPA does not 

anticipate any new HMIWI, and therefore, no impacts of the revised NSPS for new units. 

• EPA does not expect most facilities with HMIWI to be significantly impacted, whether 

the compliance costs are passed on or absorbed. 

• Of the 44 companies and other entities that own HMIWI, there is one small business, 

which owns two HMIWI impacted by the final rule. 
B-2 

FINAL RULE SUMMARY

• The final amendments to the HMIWI regulations include: 

• Strengthened existing emission limits for all regulated pollutants 

• Additional stack testing requirements for existing and new sources 

• Additional monitoring requirements for new sources 

• Annual inspections of emission control devices 

• One-time visible emissions test of ash handling operations 

• Procedures for test data submittal 

• Revised waste management plan provisions 

BACKGROUND 

• The CAA requires EPA to develop and adopt NSPS and emission guidelines for solid 

waste incineration units including hospital/medical/infectious waste incinerators. The 

Act also requires EPA to review and, if appropriate, revise the NSPS and emission 

guidelines every five years after the initial promulgation. 

• There were approximately 2,400 HMIWI operating in the United States at the time EPA 

adopted the 1997 NSPS and emission guidelines. 

• The NSPS and emission guidelines require new and existing HMIWI to control emissions 

of hydrogen chloride, carbon monoxide, lead, cadmium, mercury, particulate matter, 

dioxins/furans, nitrogen oxides, and sulfur dioxide to levels that reflect the degree of 

emission reduction based on MACT. 

• On November 14, 1997, the Sierra Club and the Natural Resources Defense Council filed 

suit in the U.S. Court of Appeals for the District of Columbia Circuit challenging EPA’s 

methodology for adopting the HMIWI regulations. 

• On March 2, 1999, the Court issued its opinion, rejecting Sierra Club’s and Natural 

Resources Defense Council’s statutory interpretations of the Act, but remanding the rule 

to EPA for further explanation of the Agency’s reasoning in determining the minimum 

regulatory emission limits or “floors” for new and existing HMIWI. 

• The Court did not vacate the regulations, stating that it was possible EPA could 

adequately address the Court’s concerns. The NSPS and emission guidelines remained in 

effect during the remand and were fully implemented by September 2002. 

• On February 6, 2007, EPA published a notice that proposed the Agency’s response to the 

questions raised in the Court’s remand and that also proposed its response to the Clean 

Air Act requirement to review the NSPS and emission guidelines every five years. 
B-3 

• After evaluating rulings by the U.S. Court of Appeals that came after the 2007 proposal 

and considering issues raised in public comments on the proposal, EPA reassessed its 

approach to setting the proposed MACT floor. 

• On December 7, 2007, EPA and the petitioner reached a settlement agreement requiring 

EPA to re-propose the rule in response to the remand by November 15, 2008, and issue a 

final rule by September 15, 2009. 

• The final action responds to the Court remand of the HMIWI regulations and implements 

the terms of the settlement agreement on the remand reached with the Sierra Club. The 

final action also satisfies the CAA requirement to conduct a review of the standards every 

five years. 

FOR MORE INFORMATION 

• Interested parties can download the final notice from EPA’s website at the following 

address: www.epa.gov/ttn/oarpg/t3pfpr.html. 

• This final rule and other background information are also available either electronically 

at http://www.regulations.gov, EPA’s electronic public docket and comment system, or 

in hardcopy at the EPA Docket Center’s Public Reading Room. 

• The Public Reading Room is located in the EPA Headquarters Library, Room 

Number 3334 in the EPA West Building, located at 1301 Constitution Ave., NW, 

Washington, DC. Hours of operation are 8:30 a.m. to 4:30 p.m. eastern standard 

time, Monday through Friday, excluding Federal holidays. 

• Visitors are required to show photographic identification, pass through a metal 

detector, and sign the EPA visitor log. All visitor materials will be processed 

through an X-ray machine as well. Visitors will be provided a badge that must be 

visible at all times. 

• Materials for this final action can be accessed using Docket ID No. 

EPA-HQ-OAR-2006-0534. 

• For further information about the final action, contact Mr. Ketan Patel of EPA’s Office of 

Air Quality Planning and Standards, Sector Policies and Programs Division, Natural 

Resources and Commerce Group at (919) 541-9736 or by e-mail at patel.ketan@epa.gov. 
Appendix C 

Applicability of the HMIWI Emission Guidelines 

C1 - Applicability Flowcharts and Venn Diagrams 

C2 - HMIWI Capacity Determination 

C3 - Small Rural Criteria
Appendix C1 

Applicability Flowcharts and Venn Diagrams 
C-3 

 APPENDIX C1--APPLICABILITY FLOWCHARTS AND VENN DIAGRAMS 

The amended HMIWI Emission Guidelines (EG) apply to individual HMIWI for which 

construction was commenced on or before June 20, 1996, as well as to those HMIWI for which 

construction was commenced after June 20, 1996 but no later than December 1, 2008, except 

where the emission limits in the original subpart Ec New Source Performance Standards (NSPS) 

are more stringent. [40 CFR 60.32e(a)(1) and (2) and 60.33e(a)(2), (a)(3), and (b)] 

Hospital/medical/infectious waste incinerators which commenced construction after December 1, 

2008 are not subject to the amended EG, but are subject to the amended subpart Ec NSPS. [40 

CFR 60.50c(a)(3)] For HMIWI modifications, applicability for the amended EG and NSPS is 

determined based on a different set of dates (March 16, 1998 instead of June 20, 1996; and April 

6, 2010 instead of December 1, 2008). [40 CFR 60.32e(a)(1) and (2) and 60.50c(a)(4)] 

An HMIWI is any device which combusts any amount of hospital waste and/or 

medical/infectious waste (as defined in section 60.51c of subpart Ec). There are several 

exemptions to the HMIWI EG as noted below. 

Combustors are not subject to the EG during periods when only pathological, low-level 

radioactive, and/or chemotherapeutic waste (all defined in section 60.51c of subpart Ec) are 

being burned, provided that facilities operating such combustors notify the Administrator of an 

exemption claim; and keep records of the periods of time when only these wastes are burned. [40 

CFR 60.32e(b)] 

Similarly, co-fired combustors are not subject to the EG, provided that facilities operating 

such combustors notify the Administrator of an exemption claim; provide an estimate of the 

weight of hospital waste, medical/infectious waste, and other fuels and/or wastes combusted; and 

keep quarterly records of the amount of hospital waste and medical/infectious waste, and other 

fuels burned. [40 CFR 60.32e(c)] Co-fired combustors are defined in section 60.51c of subpart 

Ec as units which combust 10 percent or less by weight (of the fuel feed) hospital waste and 

medical/infectious waste as measured on a calendar quarter basis. Although pathological, 

chemotherapeutic, and low-level radioactive wastes sometimes meet the definition of hospital 

waste or medical/infectious waste, they are considered Aother fuels and/or wastes@ when 

calculating the amount of hospital waste and medical/infectious waste burned in a co-fired 

combustor. [40 CFR 60.51c] 

Combustors required to have a permit under Section 3005 of the Solid Waste Disposal 

Act; combustors subject to subparts Cb, Ea, or Eb (municipal waste combustors [MWCs] larger 

than 250 tons/day); and cement kilns firing hospital and/or medical/infectious waste are not 

subject to the HMIWI EG. [40 CFR 60.32e(d), (e), and (g)] Furthermore, pyrolysis units are not 

subject to the EG. [40 CFR 60.32e(f)] Pyrolysis is defined in section 60.51c of subpart Ec as the 

endothermic gasification of hospital waste and medical/infectious waste using external energy. 

The first applicability flowchart (Figure C-1) provided below summarizes the 

applicability of the EG to the various types of combustors which may combust items that could 

be considered as hospital waste and/or medical infectious waste. Generally, the HMIWI EG 
C-4 

apply to incinerators located at hospitals, commercial medical waste incinerators, and other 

incinerators used primarily for burning hospital waste and/or medical/infections waste. [40 CFR 

60.51c] However, there are many types of combustion systems that may burn small amounts of 

waste that could be considered as hospital waste or medical/infectious waste under the 

promulgated definitions of these wastes in the HMIWI EG. [40 CFR 60.51c] The purpose of the 

HMIWI EG is not to cover every system that may burn a few items that could be considered as 

hospital or medical/infectious waste. Therefore, EPA has attempted to exclude most combustion 

systems not intended to primarily combust hospital waste or medical/infectious waste from 

coverage under the HMIWI EG through either an outright exemption or through the co-fired 

combustor provision. [40 CFR 60.32e(b)-(g)] Regulations for other types of solid waste 

incinerators have been or will be developed (e.g., Other Solid Waste Incinerators [OSWI] EG). 

Thus, burning of hospital waste or medical/infectious wastes in other solid waste incineration 

units will be covered by those regulations. The questions and answers in Figure C-1 attempt to 

clarify how certain types of combustors are either included or excluded from the HMIWI EG. 

The second applicability flowchart (Figure C-2) provided below summarizes the 

applicability of the EG and NSPS to those combustors that would be considered HMIWI based 

on Figure C-1. The amended HMIWI EG apply to those HMIWI that were subject to the 1997 

EG. [40 CFR 60.32e(a)(1)] The amended guidelines also apply to those HMIWI that were 

subject to the 1997 NSPS, except where the emission limits in the 1997 NSPS are more 

stringent. [40 CFR 60.32e(a)(2) and 60.33e(a)(3)] Specifically, the 1997 NSPS PM emission 

limit for medium HMIWI and the 1997 NSPS HCl emission limit for small HMIWI are more 

stringent than the corresponding PM and HCl emission limits in the amended EG, so the “old” 

NSPS units would be subject to the more stringent 1997 NSPS limits. [40 CFR 60.33e(a)(3), 

referencing Table 1B to subpart Ce; and 40 CFR 60.52c(a)(1), referencing Table 1A to subpart 

Ec] Those HMIWI that started construction after December 1, 2008 are subject only to the 

amended NSPS. [40 CFR 60.50c(a)(3) and (4)] The questions and answers in Figure C-2 

attempt to clarify this applicability. 

The Venn diagrams (Figure C-3) provided below summarize the overlap of the 

definitions for “Hospital Waste,” “Medical/Infectious Waste,” and “Pathological Waste” and 

show how the HMIWI regulations apply in different situations. Further explanation is provided 

with each diagram below. 
Figure C-1. Applicability Flowchart for the HMIWI Emission Guidelines, Part 1. 

C-5 
Figure C-2. Applicability Flowchart for the HMIWI Emission Guidelines, Part 2. 

C-6 
Figure C-3. Overlap of Definitions for “Hospital Waste,” “Medical/Infectious Waste,” 

and “Pathological Waste” 

C-7 

Hospital Medical/Infectious

Pathological

Waste from a hospital that is 

neither medical/infectious 

nor pathological (e.g., 

cafeteria trash, 

administrative office paper)

Medical/infectious 

waste that is not from a 

hospital and is not 

pathological waste 

(e.g., needles and other 

sharps from a nursing 

home)

Pathological waste that is not from a 

hospital and does not meet the 

definition of medical/infectious waste 

(e.g., chicken carcasses from a 

chicken farm or grocery store)

Medical/infectious 

waste from a hospital 

that is not pathological 

waste (e.g., needles 

and other sharps from 

a hospital)

Pathological 

waste from a 

hospital that is not 

medical/infectious 

Medical/infectious 

pathological waste 

from a hospital (e.g., 

gall bladder removed 

during surgery) Medical/infectious 

pathological waste 

that is not from a 

hospital (e.g., 

laboratory animals 

from a research lab 

that were exposed to 

infectious agents 

during research)

• Three terms are used in the hospital/medical/infectious waste incinerator (HMIWI) 

regulations: 

 -- Hospital Waste 

 -- Medical/Infectious Waste 

 -- Pathological Waste 

 [40 CFR 60.51c] 

• This diagram shows how the definitions of the three types of waste overlap. 

• This series of diagrams will show how the HMIWI regulations apply in different 

situations. 
Hospital Medical/Infectious

Pathological

Waste from a hospital that is 

neither medical/infectious 

nor pathological (e.g., 

cafeteria trash, 

administrative office paper)

Medical/infectious 

waste that is not from a 

hospital and is not 

pathological waste 

(e.g., needles and other 

sharps from a nursing 

home)

Medical/infectious 

waste from a hospital 

that is not pathological 

waste (e.g., needles 

and other sharps from 

a hospital)

Pathological 

waste from a 

hospital that is not 

medical/infectious 

Medical/infectious 

pathological waste 

from a hospital (e.g., 

gall bladder removed 

during surgery) Medical/infectious 

pathological waste 

that is not from a 

hospital (e.g., 

laboratory animals 

from a research lab 

that were exposed to 

infectious agents 

during research)

• The HMIWI regulations cover units burning these wastes. If a combustor burns any 

amount of these materials, it may be subject to the HMIWI regulations. [40 CFR 

60.32e(a) and 60.51c] 

• Conversely, if a combustor does not burn any of these materials, it is not subject to 

any part of the HMIWI regulations. Combustors that are not burning any of these 

materials need not notify EPA or keep records. They need not be included in State 

Plans and they need not qualify for any of the HMIWI exemptions. [40 CFR 

60.32e(d)] 

• If a combustor burns these materials in a hazardous waste incinerator, in a cement 

kiln, or in a MWC subject to the large MWC regulations, it is not subject to the 

HMIWI regulations (no matter how much of these materials it burns). [40 CFR 

60.32e(e) and (g)] 

• Pyrolysis units are not subject to the HMIWI regulations. [40 CFR 60.32e(f)] 

• The pathological and co-fired combustor exemptions are described later. [40 CFR 

60.32e(b) and (c)] 

C-8 
Hospital Medical/Infectious

Pathological

Pathological waste that is not from a 

hospital and does not meet the 

definition of medical/infectious waste 

(e.g., chicken carcasses from a 

chicken farm or grocery store)

• Consequently, if a combustor is burning these materials (alone or with other 

materials) and is not burning any of the materials from the previous diagram, it is not 

subject to any part of the HMIWI regulations (i.e., it need not notify EPA, it need not 

keep records, it need not be included on a State Plan inventory). It need not qualify 

for the pathological exemption because it is not an HMIWI. [40 CFR 60.32e(d)] 

C-9 
Hospital Medical/Infectious

Pathological

Pathological 

waste from a 

hospital that is not 

medical/infectious 

Medical/infectious 

pathological waste 

from a hospital (e.g., 

gall bladder removed 

during surgery) Medical/infectious 

pathological waste 

that is not from a 

hospital (e.g., 

laboratory animals 

from a research lab 

that were exposed to 

infectious agents 

during research)

• If there are time periods when a combustor burns only these materials, it is exempt 

from most provisions in the HMIWI regulations during those periods, but it should 

notify EPA and keep records. This is known as the pathological waste exemption. 

[40 CFR 60.32e(b)] 

• This exemption applies to combustors which burn only these materials all of the time, 

and also applies to combustors which burn only these materials some of the time 

while burning other materials at other times. [40 CFR 60.32e(b)] 

• If the combustor burns any other materials along with these materials (i.e., at the 

same time), it does not qualify for the pathological exemption (except as provided on 

the next diagram). [40 CFR 60.32e(b)] 

C-10 
Pathological waste that is not from a 

hospital and does not meet the 

definition of medical/infectious waste 

(e.g., chicken carcasses from a 

chicken farm or grocery store)

Pathological 

waste from a 

hospital that is not 

medical/infectious 

Medical/infectious 

pathological waste 

from a hospital (e.g., 

gall bladder removed 

during surgery) Medical/infectious 

pathological waste 

that is not from a 

hospital (e.g., 

laboratory animals 

from a research lab 

that were exposed to 

infectious agents 

during research)

Hospital Medical/Infectious

Pathological

• If there are time periods when a combustor burns only these materials, it is also 

exempt from most provisions in the HMIWI regulations, but it should notify EPA and 

keep records. This is part of the pathological waste exemption. [40 CFR 60.32e(b)] 

• Again, these exemption applies to combustors which burn only these items all of the 

time, and also applies to combustors which burn only these materials some of the 

time while burning other materials at other times. [40 CFR 60.32e(b)] 

• As stated previously, however, if the combustor burns any other materials along with 

these materials (i.e., at the same time), it does not qualify for the pathological 

exemption. [40 CFR 60.32e(b)] 

C-11 
Pathological

Waste from a hospital that is 

neither medical/infectious 

nor pathological (e.g., 

cafeteria trash, 

administrative office paper)

Medical/infectious 

waste that is not from a 

hospital and is not 

pathological waste 

(e.g., needles and other 

sharps from a nursing 

home)

Medical/infectious 

waste from a hospital 

that is not pathological 

waste (e.g., needles 

and other sharps from 

a hospital)

Hospital Medical/Infectious

Pathological

• A combustor which burns 10 percent or less of these materials (in aggregate) on a 

calendar quarter basis is exempt from most provisions in the HMIWI regulations, but 

it should notify EPA and keep records. This is the co-fired combustor exemption. [40 

CFR 60.32e(c)] 

• Notice that pathological waste is not counted toward the 10 percent, but all other 

hospital and medical/infectious waste is counted toward the 10 percent. [40 CFR 

60.51c] 

C-12 
Appendix C2

HMIWI Capacity Determination
C-14 

APPENDIX C2 - HMIWI CAPACITY DETERMINATION 

The HMIWI EG contain different emission limitations for the three HMIWI size 

subcategories: small, medium, and large. The three HMIWI size subcategories are based on 

waste burning capacity (pound per hour [lb/hr]). The small size subcategory consists of HMIWI 

that burn less than or equal to 200 pounds of waste per hour (< 200 lb/hr). The medium size 

subcategory includes HMIWI that burn between 200 and 500 pounds of waste per hour (> 200 to 

< 500 lb/hr). The large size subcategory includes HMIWI that burn more than 500 pounds of 

waste per hour (> 500 lb/hr). [40 CFR 60.51c] 

Generally, there are three different HMIWI design types: batch, intermittent, and 

continuous. These design types differ in the methods used to charge waste and remove ash. In 

batch HMIWI, neither waste charging nor ash removal can occur during combustion. 

Intermittent HMIWI are designed to allow waste charging, but not ash removal, during 

combustion. Continuous HMIWI are designed to allow waste charging and ash removal during 

combustion. [40 CFR 60.51c] 

Due to the differences in waste charging techniques, the methods for determining the 

maximum design waste burning capacity and maximum charge rate (defined in section 60.51c of 

subpart Ec) are different for batch HMIWI than for continuous and intermittent HMIWI. Either 

the maximum design waste burning capacity or the maximum charge rate may be used to 

determine the HMIWI size subcategory. [62 FR 48367] 

For continuous and intermittent HMIWI, maximum charge rate is defined in subpart Ec 

as 110 percent of the lowest 3-hour average charge rate measured during the most recent 

performance test demonstrating compliance with the emission limits. Table C-1 presents an 

example of the maximum charge rate calculation for an intermittent HMIWI with two days of 

initial test data. 

Maximum design waste burning capacity is defined for continuous and intermittent 

HMIWI with the following formula: [40 CFR 60.51c] 

C = PV x (15,000/8,500) 

where: 

 C = HMIWI capacity (lb/hr), 

 PV = primary chamber volume (ft3

), 

 15,000 = primary chamber heat release rate factor (Btu/ft3

/hr), and 

 8,500 = standard waste heating value (Btu/lb). 

For batch HMIWI, the maximum charge rate is defined in section 60.51c of subpart Ec as 

110 percent of the lowest daily charge rate measured during the most recent performance test 

demonstrating compliance with the emission limits. For example, suppose a batch HMIWI was 

charged with 1,400 lb on day 1 and 1,700 lb on day 2 of an initial compliance test. The 

maximum charge rate for this HMIWI would be 110 percent of 1,400 lb/day (the lowest daily 

charge rate) or 1,540 lb/day. 
Table C-1. Maximum Charge Rate 

Maximum design waste burning capacity is defined for batch HMIWI with the following 

formula: [40 CFR 60.51c] 

 Example Calculation 

Charge log (lb/hr) 3-hour average (lb/hr) 

345 -- 

376 -- 

359 360 

341 359 

387 362 

361 363 

368 372 

337 355 

329 345 

358 341 

362 350 

343 354 

364 356 

381 363 

Lowest 3-hour average charge rate during initial testing = 

341 lb/hr 

Maximum charge rate = 1.1 x 341 = 375 lb/hr

C = PV x (4.5/8) 

where: 

 C = HMIWI capacity (lb/hr), 

 Pv = primary chamber volume (ft3

), 

 4.5 = waste density (lb/ft3

), and 

 8 = typical hours of operation for a batch HMIWI (hr). 

Table C-2 summarizes the criteria specified in the EG for maximum design waste 

burning capacity and for maximum charge rate for the three HMIWI size subcategories. 

C-15 
C-16 

For convenience, Table C-3 presents the range of primary chamber volumes for each 

subcategory for batch and continuous/intermittent HMIWI. These primary chamber volumes 

were obtained from the above equations for maximum design waste burning capacity for each 

size subcategory. 

Table C-2. Summary of Criteria for Determining HMIWI Size Category as Stated in the 

Emission Guidelines 

Size Criteria 

HMIWI size subcategory 

Small Medium Large 

Maximum design waste burning capacity 

(lb/hr) 

<200 >200 and <500 >500 

Maximum charge rate for batch HMIWI 

(lb/day) 

<1,600 >1,600 and <4,000 >4,000 

Maximum charge rate for intermittent and 

continuous HMIWI (lb/hr) 

<200 >200 and <500 >500 

Table C-3. Primary Chamber Volumes for Use in Determining 

Maximum Design Waste Burning Capacity 

HMIWI Type 

Maximum design waste burning capacity (lb/hr) 

<200a >200 to < 500b >500c

Primary chamber volume for batch 

HMIWI (ft3) 

< 356 > 356 to < 889 > 889 

Primary chamber volume for intermittent 

or continuous HMIWI (ft3

) 

< 113 > 113 to < 283 > 283 

a

Small HMIWI size subcategory. 

b

Medium HMIWI size subcategory. 

c

Large HMIWI size subcategory. 

In cases where the maximum design waste burning capacity places an HMIWI in one size 

subcategory and the maximum charge rate places the same HMIWI in a different size 

subcategory, the maximum charge rate prevails. [62 FR 48367] Most HMIWI operate at around 

two-thirds of their design capacity; very few HMIWI operate at their maximum design waste 

burning capacity. The maximum design waste burning capacity of an HMIWI is fixed and 

cannot be changed. The maximum charge rate, on the other hand, can be controlled by the 

HMIWI operator. The EG allow an HMIWI used to burn less waste than its design capacity to 

change its size category. For example, an HMIWI with a maximum design waste burning 

capacity of 300 lb/hr (e.g., a medium HMIWI by design), may only be used to burn 150 lb/hr. 

By virtue of the maximum charge rate, such an HMIWI could be considered as a small HMIWI 

for purposes of the EG, and would be allowed to meet slightly less stringent emission limits. 
C-17 

The HMIWI would be bound by the maximum charge rate in its state operating permit for 

enforcement purposes. 

Larger HMIWI which derate their capacities to be considered as smaller HMIWI need to 

account for the 110 percent operating range specified in the EG when establishing their 

permitted maximum charge rate. For example, a facility operating a 300 lb/hr HMIWI needs to 

ensure that the lowest 3-hour average charge rate does not exceed 182 lb/hr if the HMIWI is to 

be considered a small HMIWI. This is because the 110 percent operation applied to the 182 

lb/hr average charge rate will establish the maximum charge rate at 200 lb/hr (i.e., the cutoff for 

the small HMIWI size subcategory). Likewise, to fall into the medium subcategory, a facility 

operating a large HMIWI needs to ensure that the lowest 3-hour average charge rate does not 

exceed 455 lb/hr because the 110 percent operation will establish the maximum charge rate at 

500 lb/hr (i.e., the cutoff for the medium HMIWI size subcategory). 
Appendix C3 

Small Rural Criteria
C-19 

APPENDIX C3 - SMALL RURAL CRITERIA 

The rural criteria in the EG state that the small HMIWI: (1) be located more than 50 

miles (straight line distance) from the boundary of the nearest Standard Metropolitan Statistical 

Area (SMSA) and (2) burn less than 2,000 pounds per week (lb/wk)of hospital waste and 

medical/infectious waste. [40 CFR 60.33e(b)] 

 Standard Metropolitan Statistical Areas (now called simply Metropolitan Statistical 

Areas [MSAs]) are defined by the Office of Management and Budget (OMB). For the purposes 

of the EG, the SMSAs are based on the OMB June 30, 1993 listing of SMSAs [40 CFR 60.31e], 

which is available on the TTN Air Toxics Website for HMIWI at the following address: 

http://www.epa.gov/ttn/atw/129/hmiwi/rihmiwi.html. 
Appendix D 

HMIWI Implementation Timeline
Compliance Window

Increments of progress 

required6

1 74 FR 51368.2 Section 129(b)(2) requires State Plans be submitted not later than one year after promulgation of the rule.3 Section 129(b)(2) requires EPA to approve or disapprove a State Plan within 180 days of submission.4 Section 129(b)(3) requires EPA to develop a Federal Plan within 2 years of rule promulgation (if necessary).5 Due 12 months after EPA approval of State Plan under section 60.39e of subpart Ce unless the State has granted an extension to a source (u

approval of State Plan but not less than 5 years after promulgation). Note: Section 129(f)(2) requires expeditious compliance.

6 Section 60.24(e)(1) of subpart B requires legally enforceable increments of progress for any compliance schedule extending beyond 12 month

approval. Section 60.39e(c)(1)-(9) of subpart Ce and section 60.21 of subpart B list suggested increments of progress, and section 60.21 of surequired increments of progress.Notes:

Subpart B General requirements for all section 111(d) State Plans. Amended 12/19/95 to allow subsequent subparts (e.g., subpart Ce) to

supersede subpart B.

Subpart Ce Emission Guidelines for HMIWI.

10/6/2010

State Plans

Due2

10/6/2011

Federal Plan

Published4

10/6/2009

Revised Rule

Promulgated1

4/6/2011

EPA Approves/

Disapproves

State Plans3

4/6/2012

Compliance Due5

Figure D-1. HMIWI Implementation Timeline. 

D-1 
Appendix E 

EPA Regional and State/Local Agency Contacts 

E1 EPA Regional HMIWI Rule Contacts 

E2 State Contacts
Appendix E1 

EPA Regional HMIWI Rule Contacts
E-1 

EPA REGIONAL HMIWI RULE CONTACTS

Regional Contact Address Phone # 

Region I (Connecticut, Massachusetts, Maine, New Hampshire, Rhode Island, Vermont) Contact: Ian Cohen 

U.S. Environmental Protection Agency, Region I 5 Post Office Square, Suite 100 Mail Code: OEP05-2 Boston, MA 02109-3912 

(617) 918-1655 cohen.ian

Region II  (New York, New Jersey, Puerto Rico, Virgin Islands) Contact: Ted Gardella 

U.S. Environmental Protection Agency, Region II 290 Broadway New York, NY 10007-1866 

(212) 637-3892 gardella.a

Region III (Virginia, Delaware, District of Columbia, Maryland, Pennsylvania, West Virginia) Contact: James B. Topsale 

U.S. Environmental Protection Agency, Region III 1650 Arch Street Mail Code: 3AP10 Philadelphia, PA 19103-2029 

(215) 814-2190 topsale.ji

Region IV (Florida, Georgia, North Carolina, Alabama, Kentucky, Mississippi, South Carolina, Tennessee) Contacts: Donnette Sturdivant  Daniel Garver 

U.S. Environmental Protection Agency, Region IV 61 Forsyth Street, SW Mail Code: 9T25 Atlanta, GA 30303 

Sturdivant: (404) 562-9431 Garver: (404) 562-9839 

sturdivan

garver.da

Region V (Minnesota, Wisconsin, Illinois, Indiana, Michigan, Ohio) Contact: Margaret Sieffert 

U.S. Environmental Protection Agency, Region V 77 W. Jackson Blvd. Mail Code: AT-18J Chicago, IL 60604 

(312) 353-1151 sieffert.m

Region VI (Arkansas, Louisiana, New Mexico, Oklahoma, Texas) Contact: Steve Thompson 

U.S. Environmental Protection Agency, Region VI 1445 Ross Avenue, Suite 1200 Mail Code: 6EN 

(214) 665-2769 thompso
E-2 

Regional Contact Address Phone # 

Dallas, TX 75202-2733 

Region VII (Iowa, Kansas, Missouri, Nebraska) Contact: Lisa Hanlon 

U.S. Environmental Protection Agency, Region VII 901 N. 5th St. Kansas City, KS 66101 

(913) 551-7599 hanlon.lis

Region VIII (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming) Contact: Christopher Razzazian 

U.S. Environmental Protection Agency, Region VIII 1595 Wynkoop Street Mail Code: 8P-AR Denver, CO 80202-1129 

(303) 312-6648 razzazian

Region IX (Arizona, California, Hawaii, Nevada) Contact: Joseph Lapka 

U.S. Environmental Protection Agency, Region IX 75 Hawthorne Street Mail Code: AIR-5 San Francisco, CA 94105 

(415) 947-4226 Lapka.Jo

Region X (Alaska, Idaho, Oregon, Washington) Contact: Heather Valdez 

U.S. Environmental Protection Agency, Region X 1200 Sixth Avenue, Suite 900 Mail Code: AWT-107 Seattle, WA 98101 

(206) 553-6220 valdez.he
Appendix E2 

State Contacts 
STATE CONTACTS

State Contact Address Phone # 

Alabama Contact: Geraline Handsome City of Huntsville Contact: Danny Shea Jefferson County Contact: Corey Masuca 

Alabama Department of Environmental Management Air Division 1751 Congressman W.L. Dickenson Way Montgomery, AL 36109-2608 City of Huntsville Department of Natural Resources and Environmental Management 305 Church Street Huntsville, AL 35801 Jefferson County Department of Health P.O. Box 2648 1400 Sixth Avenue South Birmingham, AL 35202-2648 

(334) 271-7700 (256) 427-5750 (205) 930-1595 

gh@adem

danny.she

corey.mas

Alaska Contact: Krista Thieman 

Alaska Department of Environmental Conservation  Division of Air Quality - Air Permits Program 619 E. Ship Creek, Ste. 249 Anchorage, AK 99501 

(907) 269-471 krista.thiem

Arizona Contact: Thomas Luch Pinal County 

Arizona Department of Environmental Quality Air Quality Division 3033 North Central Avenue 5th Floor Phoenix, AZ 85012 Pinal County Air Quality Control District 

(602) 771-4480 “Thomas C

Luch.Thom"Scott DiB

E-4 
State Contact Address Phone # 

Contact: Scott Dibiase Maricopa County Contact: Doug Erwin 

P.O. Box 987 Florence, AZ 85132 Maricopa County Air Quality Department 1001 N. Central Ave., Suite 400 Phoenix, AZ 85004 

(520) 866-6969 (602) 372-3033 

scott.dibiaDouglas E<DouglasE

Arkansas Contact: Mike Porta 

Arkansas Department of Environmental Quality 5301 Northshore Drive North Little Rock, AR 72118-5317 

501-682-0752 porta@ade

California Contact: Michelle Komlenic 

California Air Resources Board 1000 “I” Street P.O. Box 2815 Sacramento, CA 95812 

(916) 322-3926 mkomleni

Colorado Contact: Dena Wojtach 

Air Pollution Control Division Colorado Department of Public Health and the Environment 4300 Cherry Creek Dr. S. Denver, Colorado 80246-1530 

(303) 692-3147 dena.wojta

Connecticut Contact: Merrily Gere 

Connecticut Department of Environmental Protection Bureau of Air Management 79 Elm Street, 5th floor Hartford, CT 06106-5127 

(860) 424-3416 merrily.ge

Delaware Contact: James Sneed 

Delaware Division of Air & Waste Management 715 Grantham Lane New Castle, DE 19702 

(302) 739-9402 James.sne

District of Columbia Contact: Stephen Ours 

District of Columbia Department of Consumer and Regulatory Affairs Environmental Regulation Administration Air Resources Management Division 

(202) 535-1747 Stephen.ou

E-5 
State Contact Address Phone # 

2100 MLK Avenue, SE, Suite 203 Washington, DC 20020-5732 

Florida Contacts: Larry George  John Glunn  Lynn Scearce 

Florida Department of Environmental Protection Air Resources Management Division Twin Towers Office Building 2600 Blair Stone Road Tallahassee, FL 32399-2400 

-- 

(850) 921-9509 (850) 921-9551 

larry.georgjohn.glunnlynn.scear

Georgia Contact: Susan Jenkins 

Georgia Department of Natural Resources Environmental Protection Division Air Protection Branch 4244 International Parkway, Suite 120 Atlanta, GA 30354 

(404) 362-4598 susan.jenk

Hawaii Contact: Nolan Hirai 

Hawaii Department of Health Clean Air Branch P.O. Box 3378 Honolulu, HI 96801 

(808) 586-4200 “Hirai, No

nolan.hira

Idaho Contact: Carl Brown 

Idaho Division of Environmental Quality 1410 North Hilton Boise, ID 83706-1290 

(208) 373-0206 carl.brown

Illinois Contact: Edwin C. Bakowski 

Illinois Environmental Protection Agency Division of Air Pollution Control 1021 North Grand Avenue East P.O. Box 19276 Springfield, IL 62794-9276 

(217) 782-2113 ed.bakows

Indiana Contact: Susan Bem 

Indiana Department of Environmental Management 100 North Senate Avenue Mail Code 61-50 Indianapolis, IN 46204-2251 

(317) 233-5697 sbem@ide

E-6 
State Contact Address Phone # 

Iowa Contact: Christine Paulson 

Iowa Department of Natural Resources Air Quality Bureau 7900 Hickman Rd., Suite 1 Windsor Heights, , IA 50324 

(515) 242-5154 Christine.P

Kansas Contact: Miles Stotts 

Kansas Department of Health and Environment Bureau of Air and Radiation 1000 SW Jackson St, Suite 310 Topeka, KS 66612-1366 

(785) 296-1615 mstotts@k

Kentucky Contact: Sreenivas (Sree) Kesaraju Jefferson County Contact: Paul Aud 

Kentucky Natural Resources & Environmental Protection Cabinet Division for Air Quality 803 Schenkel Lane Frankfort, KY 40601 Air Pollution Control District of Jefferson County 850 Barrett Avenue, Suite 200 Louisville, KY 40204-1745 

(502) 564-3999 x4408 (502) 574-7234 

sreenivas.kpaul.aud@

Louisiana Contact: Michael Vince 

Louisiana Department of Environmental Quality Office of Air Quality and Radiation Protection P.O. Box 82135 Baton Rouge, LA 70884-2135 

(225) 219- 3482 Michael.V

Maine Contact: Lisa Higgins 

Maine Department of Environmental Protection Bureau of Air Quality 17 State House Station Augusta, ME 04333-0017 

(207) 287-7023 Lisa.Higgi

Maryland Contact: Husain Waheed 

Maryland Department of the Environment Air and Radiation Management Administration Regulation Development Division 2500 Broening Highway Baltimore, MD 21224 

(410) 537-3238 hwaheed@

E-7 
State Contact Address Phone # 

Massachusetts Contact: Marc Wolman 

Massachusetts Department of Environmental Protection Division of Air Quality Control One Winter Street, 7th Floor Boston, MA 02108 

(617) 292-5915 Marc.Wol

Michigan Contact: Mary Charley 

Michigan Department of Natural Resources and Environment P.O. Box 30473 Lansing, MI 48909 

(517) 373-7080 charleym@

Minnesota Contact: Anne Jackson 

Minnesota Pollution Control Agency 520 Lafayette Road N St. Paul, MN 55155 

(651) 757-2460 anne.jacks

Mississippi Contact: Danny Jackson 

Mississippi Department of Environmental Quality Air Division P.O. Box 10385 Jackson, MS 39289-0385 

(601) 961-5225 danny_jac

Missouri Contact: Paul Jeffery 

Missouri Department of Natural Resources Division of Environmental Quality Air Pollution Control Program P.O. Box 176 Jefferson City, MO 65102 

(573) 751-4817 Paul.Jeffer

Montana Contact: Debbie Skibicki 

Air and Waste Management Bureau Air Permitting Department of Environmental Quality P.O. Box 200901 Helena, MT 59620-0901 

(406) 444-1472 dskibicki@

Nebraska Contact: Stephenie Moyer 

Nebraska Department of Environmental Quality Air and Waste Management Division 1200 N Street, Suite 400 Box 98922 

(402) 471-0019 stephenie.

E-8 
State Contact Address Phone # 

Lincoln, NE 68509-8922 

Nevada Contact: Adele Malone 

Nevada Division of Environmental Protection Bureau of Air Quality Planning 901 S. Stewart St., Suite 4001 Carson City, NV 89701 

(775) 687-9356 amalone@

New Hampshire Contact: Barbara Hoffman 

New Hampshire Department of Environmental Services Air Resources Division 29 Hazen Drive PO Box 95 Concord, NH 03302-0095 

(603) 271-7874 barbara.ho

New Jersey Contact: Lisa Ehrlich 

New Jersey Department of Environmental Protection Bureau of Technical Services P.O. Box 27 Trenton, New Jersey 08625 

(609) 292-2450 lisa.ehrlich

New Mexico Contact: Steve Dubyk 

New Mexico Environment Department, Environmental Protection Division, Air Quality Bureau Harold Runnels Building, Room S2100 P.O. Box 26110 Santa Fe, NM 87502 

(505) 955-8025 Steve.Dub

New York Contact: Mark Lanzafame 

New York State Department of Environmental Conservation Division of Air Resources 50 Wolf Road (Room 108) Albany, NY 12233-3254 

(518) 402-8403 mrlanzaf@

E-9 
State Contact Address Phone # 

North Carolina Contact: Paul Grable  Mike Abraczinskas Forsyth County Contact: Keith Tart Mecklenburg County Contact: Joan Liu Western NC Contact: Ashley Featherstone 

North Carolina Department of Environment, Health, and Natural Resources Division of Air Quality P.O. Box 29580 Raleigh, NC 27626-0580 Forsyth County Environmental Affairs Department 537 North Spruce Street Winston-Salem, NC 27101 Mecklenburg County Department of Environmental Protection 700 North Tryon Road, Suite 205 Charlotte, NC 28202-2236 Western NC Regional Air Pollution Control Agency 49 Mt. Carmel Road Asheville, NC 28806 

(919) 733-1468 (919) 715-3743 (336) 703-2428 

-- 

(828) 250-6777 

paul.grablmichael.abtartkf@coJoan.Liu@ashley.feath

North Dakota Contact: Casey Mutzenberger 

Division of Air Quality North Dakota Department of Health Gold Seal Center – 918 E. Divide Bismark, ND 58501-1947 

(701) 328-5188 cmutzenbe

Ohio Contact: Dana Thompson 

Ohio Environmental Protection Agency P.O. Box 1049 Columbus, OH 43216-1049 

(614) 644-3701 dana.thom

E-10 
State Contact Address Phone # 

Oklahoma Contact: Cheryl Bradley 

Oklahoma Department of Environmental Quality Air Quality Division 4545 North Lincoln Boulevard - Suite 250 Oklahoma City, OK 73105-3483 

405-702-4218 Cheryl.Br

Oregon Contact: Jerry Ebersole 

Oregon Department of Environmental Quality Air Quality Division 811 Southwest Sixth Avenue Portland, OR 97204-1390 

(503) 229-6974 ebersole.g

Pennsylvania (excl.Alleg. Co.) Contact: Baldev Kohli Philadelphia County Contact: Edward Braun Allegheny County Contact: Jayme Graham 

Pennsylvania Department of Environmental Protection Commonwealth of Pennsylvania Administration Rachael Carson Office Building, 12th Floor. 400 Market Street Harrisburg, PA 17105-8468 Philadelphia County Air Management Services Department of Public Health Spelman Building 321 University Avenue Philadelphia, PA 19104 Allegheny County Health Department Bureau of Environmental Quality 310 39th Street Pittsburgh, PA 15201-1891 

Kohli: (717) 772-3974 Braun: (215) 685-9476 Graham: (412) 578-8129 

bkohli@stedward.brjgraham@

Puerto Rico Contact: Luis Sierra 

Puerto Rico Environmental Quality Board Air Programs Area P.O. Box 11488 Santurce, Puerto Rico 00910 

(787) 767-8181, ext. 3247 

luissierra@

E-11 
State Contact Address Phone # 

Rhode Island Contact: Gina Friedman 

Rhode Island Department of Environmental Management Office of Air Resources 235 Promenade Street Providence, RI 02908 

(401) 222-2808, ext 7016 

gina.friedm

South Carolina Contact: Maeve Mason  Tony Lofton 

South Carolina Department of Health and Environmental Control Bureau of Air Quality Control 2600 Bull Street Columbia, SC 29201 

(803) 898-2230 

(803) 898-7217 

masonmr@loftonat@

South Dakota Contact: Marlys Heidt 

Air Quality Program Department of Environment and Natural Resources Joe Foss Building , PMB 2020 523 East Capitol Pierre, South Dakota 57501-3182 

(605) 773-4213 marlys.hei

E-12 
State Contact Address Phone # 

Tennessee Contact: Lacey Hardin Chattanooga-Hamilton County Contact: Errol Reksten Knox County Contact: Steve McDaniel Memphis-Shelby County Contact: Bob Rogers Nashville-Davidson County Contact: John Finke 

Tennessee Department of Conservation and Environment Division of Air Pollution Control 401 Church Street L & C Annex, 9th Floor Nashville, TN 37243-1531 Chattanooga-Hamilton County Air Pollution Control Bureau 3511 Rossville Boulevard Chattanooga, TN 37407 Knox County Department of Air Pollution Control 400 Main Street City/County Building, Room 437 Knoxville, TN 37902-2405 Pollution Control Section Memphis-Shelby County Health Department 814 Jefferson Avenue, Room 437 Memphis, TN 38105 Air Pollution Control Division Nashville-Davidson County 311 23rd Avenue, North Nashville, TN 37203 

-- 

(423) 643-5986 (865) 215-5913 (901) 544-7587 (615) 340-5653 

lacey.hardreksten_e@asmcdaniebob.rogersjohn.finke

Texas Contact: Beryl Thatcher 

Texas Commission on Environmental Quality P.O. Box 13087 Austin, TX 78711-3087 

(512) 239-5314 BTHATC

E-13 
State Contact Address Phone # 

Utah Contact: Robert Grandy 

Division of Air Quality Utah Dept of Environmental Quality PO Box 144820 Salt Lake City, UT 84114-4820 

(801) 536-4024 rgrandy@

Vermont Contact: Doug Elliott 

Vermont Department of Environmental Conservation Air Pollution Control Division 103 South Main Street Building 3 South Waterbury, VT 05671-0402 

(802) 241-3845 Doug.Ellio

Virginia Contact: Karen Sabasteanski 

Virginia Department of Environmental Air Quality Commonwealth of Virginia P.O. Box 10009 Richmond, VA 23240-0009 

(804) 698-4426 kgsabastea

U.S. Virgin Islands Contacts: Dr. Nadine Noorhasan Verline Marcellin 

Virgin Islands Department of Planning and Natural Resources Wheatley Center II St. Thomas, VI 00802 

Noorhasan/Marcellin: (340) 773-1082 or (340) 774-3320 

nadine.nooverline.ma

Washington State Contact: Elena Guifoil Puget Sound Clean Air Agency Contact: Claude Williams Olympic Region Clean Air Agency Contact: Mark Goodin 

Washington Department of Ecology Engineering and Technical Services P.O. Box 47600 Olympia, WA 98504-7600 1904 Third Avenue - Suite 105 Seattle, WA 98101 2940-B Limited Lane NW Olympia, WA 98502 

(360) 407-6855 (206) 689-4066 (360) 586-1044 x108 

egui461@claudew@mark.good

E-14 
State Contact Address Phone # 

Southwest Clean Air Agency Contact: John St Clair Northwest Clean Air Agency Contact: Mark Buford Yakima Regional Clean Air Authority Contact: Hasan Tahat Spokane County Air Pollution Control Authority Contact: April Wastby Benton County Clean Air Authority Contact: Robin Priddy 

11815 NE 99th Street, Suite 1294 

Vancouver, WA 98682 1600 South Second Street Mount Vernon, WA 98273 6 South 2nd Street, Rm 1016 

Yakima, WA 98901 3104 E. Augusta Ave. Spokane, WA 99207 114 Columbia Point Drive, Suite C Richland, WA 99352 

(360) 574-3058 ext 127 (360) 428-1617 ext 207 (509) 834-2050 ext 48 (509) 477-4727 ext 105 (509) 783-1304 

john@swcmark@nwhasan@yrawestby@rpri@bcaa

West Virginia Contact: Lucy Pontiveros 

West Virginia Division of Environmental Protection Office of Air Quality 1558 Washington Street, East Charleston, WV 25311-2599 

(304) 926-0499 Lucia.S.Po

Wisconsin Contact: Ralph Patterson 

Wisconsin Department of Natural Resources P.O. Box 7921 Madison, WI 53707-7921 

(608) 267-7546 ralph.patte

Wyoming Contact: Lori Bocchino 

Air Quality Division Wyoming Department of Environmental Quality Herscher Building 

(307) 777-8578 lbocch@w

E-15 
E-16 

State Contact Address Phone # 

122 West 25th Street Cheyenne, WY 82002 
Appendix F 

HMIWI Emission Factors
F-1 

APPENDIX F--HMIWI EMISSION FACTORS 

The pollutants emitted from hospital/medical/infectious waste incinerators (HMIWI) 

include the following: 

• metals (cadmium, lead, and mercury), 

• particulate matter (PM), 

• acid gases (hydrogen chloride, HCl, and sulfur dioxide, SO2), 

• organic compounds (dioxins and furans), 

• carbon monoxide (CO), and 

• nitrogen oxides (NOX). 

As noted in section 3 of this document, data from continuous emission monitoring 

systems (CEMS) and stack sampling results are preferred for estimating emissions for the 

emission inventories included in states’ section 111(d)/129 State Plans. However, where CEMS 

and stack sampling results are missing, emission factors are an acceptable alternative. Emission 

factors for each of the pollutants listed above are included in Table F-1. The emission factors 

presented in Table F-1 were generated based on test data used for development of the amended 

Emission Guidelines for HMIWI. The test data used to develop the emission factors in Table 

F-1 was thoroughly reviewed for accuracy and reliability prior to use for the amended Emission 

Guidelines. Therefore, the emission factors presented in Table F-1 are appropriate emission 

factors for use in developing the updated emission inventory to be submitted in states’ 

revised/amended or new section 111(d)/129 State Plans. The AP-42 emission factors may be 

used as well. 
F-2 

Table F-1. Emission Factors for HMIWI 

Pollutant 

Emission factors, lb emitted per lb waste charged

Combustion Control Wet Scrubbers Dry scrubbers D

Total CDD/CDF 1.90E-06 2.66E-07 w/o carbon: 2.45E-07 

w/ carbon: 9.46E-08 

w

w

CDD/CDF TEQ 3.83E-08 4.12E-09 w/o carbon: 4.19E-09 

w/ carbon: 2.96E-09 

w

w

CO w/ 1-sec combustion: 1.09E-04 

w/ 2-sec combustion: 7.08E-05 

all HMIWI (including unknown retention time): 9.47E-05 

PM 1.44E-03 6.67E-04 2.28E-04 HCl 4.34E-03 6.79E-05 5.77E-04 Pb 1.41E-05 4.85E-06 6.09E-07 SO2 1.03E-03 2.12E-04 2.84E-04 Hg 2.85E-06 1.04E-06 w/o carbon: 1.92E-06 

w/ carbon: 4.95E-07 

w

w

Cd 2.37E-06 4.16E-07 5.54E-08 NOx w/o NOX control: 3.69E-03 

w/ NOX control: 1.37E-03 

Source: Memorandum from T. Holloway, RTI, to K. Patel, EPA. July 6, 2009. Revised Baseline Emissions and Reductions for Existing and New HMIWI. 
F-3 

When estimating emissions from emission factors, the amount of waste burned per year 

at a facility is simply multiplied by the pollutant emission factor. For example, to estimate the 

annual Pb emissions (lb/yr) for an HMIWI which burns lb of medical/infectious waste per year 

and is equipped with a wet scrubber, the following calculation is performed: 

(424,000 lb waste/yr) x (4.85E-06 lb Pb/lb waste) = 2.06 lb Pb/yr 

When using the HMIWI emission factors to estimate emissions, keep in mind that they 

are average values, and that emissions from HMIWI are greatly affected by the composition of 

the waste and may vary from facility to facility. As stated previously, actual and reliable 

facility-specific CEMS and stack sampling results should be used in place of emission factors 

where available. The preferred hierarchy for estimating emissions is as follows: (1) CEMS data, 

(2) stack sampling results, and (3) emission factors. 
Appendix G 

Clean Air Act Section 111(d)
G-2 

APPENDIX G--CLEAN AIR ACT SECTION 111(d) 

Note: The State Plans for HMIWI must be developed to satisfy the requirements 

of both Section 111(d) and Section 129. Where conflicts arise, Section 129 takes 

precedent. Refer to Appendix H for the text of Section 129. 

 (d)(1) The Administrator shall prescribe regulations which shall establish a procedure similar 

to that provided by Section 110 under which each State shall submit to the Administrator a plan 

which (A) establishes standards of performance for any existing source for any air pollutant (i) 

for which air quality criteria have not been issued or which is not included on a list published 

under Section 108(a) or 112(b)(1)(A) but (ii) to which a standard of performance under this 

section would apply if such existing source were a new source, and (B) provides for the 

implementation and enforcement of such standards of performance. Regulations of the 

Administrator under this paragraph shall permit the State in applying a standard of performance 

to any particular source under a plan submitted under this paragraph to take into consideration, 

among other factors, the remaining useful life of the existing source to which such standard 

applies. 

 (2) The Administrator shall have the same authority-- 

 (A) to prescribe a plan for a State in cases where the State fails to submit a satisfactory plan as 

he would have under Section 110(c) in the case of failure to submit an implementation plan, and 

 (B) to enforce the provisions of such plan in cases where the State fails to enforce them as he 

would have under sections 113 and 114 with respect to an implementation plan. In promulgating 

a standard of performance under a plan prescribed under this paragraph, the Administrator shall 

take into consideration, among other factors, remaining useful lives of the sources in the 

category of sources to which such standard applies. 
Appendix H 

Clean Air Act Section 129
H-2 

APPENDIX H--SECTION 129 STATUTORY LANGUAGE 

Note: The State Plans for HMIWI must be developed to satisfy the requirements 

of both Section 111(d) and Section 129. Where conflicts arise, Section 129 takes 

precedent. Refer to Appendix G for the text of Section 111(d). 

SEC. 129. SOLID WASTE COMBUSTION. 

 (a) NEW SOURCE PERFORMANCE STANDARDS. 

 (1) IN GENERAL. -- (A) The Administrator shall establish performance standards and other 

requirements pursuant to Section 111 and this section for each category of solid waste 

incineration units. Such standards shall include emissions limitations and other requirements 

applicable to new units and guidelines (under Section 111(d) and this section) and other 

requirements applicable to existing units. 

 (B) Standards under Section 111 and this section applicable to solid waste incineration units 

with capacity greater than 250 tons per day combusting municipal waste shall be promulgated 

not later than 12 months after the date of enactment of the Clean Air Act Amendments of 1990. 

Nothing in this subparagraph shall alter any schedule for the promulgation of standards 

applicable to such units under Section 111 pursuant to any settlement and consent decree entered 

by the Administrator before the date of enactment of the Clean Air Act Amendments of 1990, 

provided that, such standards are subsequently modified pursuant to the schedule established in 

this subparagraph to include each of the requirements of this section. 

 (C) Standards under Section 111 and this section applicable to solid waste incineration units 

with capacity equal to or less than 250 tons per day combusting municipal waste and units 

combusting hospital waste, medical waste and infectious waste shall be promulgated not later 

than 24 months after the date of enactment of the Clean Air Act Amendments of 1990. 

 (D) Standards under Section 111 and this section applicable to solid waste incineration units 

combusting commercial or industrial waste shall be proposed not later than 36 months after the 

date of enactment of the Clean Air Act Amendments of 1990 and promulgated not later than 48 

months after such date of enactment. 

 (E) Not later than 18 months after the date of enactment of the Clean Air Act Amendments of 

1990, the Administrator shall publish a schedule for the promulgation of standards under 

Section 111 and this section applicable to other categories of solid waste incineration units. 

 (2) EMISSIONS STANDARD. -- Standards applicable to solid waste incineration units 

promulgated under Section 111 and this section shall reflect the maximum degree of reduction in 

emissions of air pollutants listed under section (a)(4) that the Administrator, taking into 

consideration the cost of achieving such emission reduction, and any non-air quality health and 

environmental impacts and energy requirements, determines is achievable for new or existing 

units in each category. The Administrator may distinguish among classes, types (including 

mass-burn, refuse-derived fuel, modular and other types of units), and sizes of units within a 

category in establishing such standards. The degree of reduction in emissions that is deemed 

achievable for new units in a category shall not be less stringent than the emissions control that 

is achieved in practice by the best controlled similar unit, as determined by the Administrator. 

Emissions standards for existing units in a category may be less stringent than standards for new 

units in the same category 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 
H-3 

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). 

 (3) CONTROL METHODS AND TECHNOLOGIES. -- Standards under Section 111 and this 

section applicable to solid waste incineration units shall be based on methods and technologies 

for removal or destruction of pollutants before, during, or after combustion, and shall incorporate 

for new units siting requirements that minimize, on a site specific basis, to the maximum extent 

practicable, potential risks to public health or the environment. 

 (4) NUMERICAL EMISSIONS LIMITATIONS. -- The performance standards promulgated 

under Section 111 and this section and applicable to solid waste incineration units shall specify 

numerical emission limitations for the following substances or mixtures: particulate matter (total 

and fine), opacity (as appropriate), sulfur dioxide, hydrogen chloride, oxides of nitrogen, carbon 

monoxide, lead, cadmium, mercury, and dioxins and dibenzofurans. The Administrator may 

promulgate numerical emissions limitations or provide for the monitoring of postcombustion 

concentrations of surrogate substances, parameters or periods of residence time in excess of 

stated temperatures with respect to pollutants other than those listed in this paragraph. 

 (5) REVIEW AND REVISION. -- Not later than 5 years following the initial promulgation of 

any performance standards and other requirements under this section and Section 111 applicable 

to a category of solid waste incineration units, and at 5 year intervals thereafter, the 

Administrator shall review, and in accordance with this section and Section 111, revise such 

standards and requirements. 

 (b) EXISTING UNITS. 

 (1) GUIDELINES. -- Performance standards under this section and Section 111 for solid waste 

incineration units shall include guidelines promulgated pursuant to Section 111(d) and this 

section applicable to existing units. Such guidelines shall include, as provided in this section, 

each of the elements required by subsection (a) (emissions limitations, notwithstanding any 

restriction in Section 111(d) regarding issuance of such limitations), subsection (c) (monitoring), 

subsection (d) (operator training), subsection (e) (permits), and subsection (h)(4) (residual risk). 

 (2) STATE PLANS. -- Not later than 1 year after the Administrator promulgates guidelines for 

a category of solid waste incineration units, each State in which units in the category are 

operating shall submit to the Administrator a plan to implement and enforce the guidelines with 

respect to such units. The State plan shall be at least as protective as the guidelines promulgated 

by the Administrator and shall provide that each unit subject to the guidelines shall be in 

compliance with all requirements of this section not later than 3 years after the State plan is 

approved by the Administrator but not later than 5 years after the guidelines were promulgated. 

The Administrator shall approve or disapprove any State plan within 180 days of the submission, 

and if a plan is disapproved, the Administrator shall state the reasons for disapproval in writing. 

Any State may modify and resubmit a plan which has been disapproved by the Administrator. 

 (3) FEDERAL PLAN. -- The Administrator shall develop, implement and enforce a plan for 

existing solid waste incineration units within any category located in any State which has not 

submitted an approvable plan under this subsection with respect to units in such category within 

2 years after the date on which the Administrator promulgated the relevant guidelines. Such plan 

shall assure that each unit subject to the plan is in compliance with all provisions of the 

guidelines not later than 5 years after the date the relevant guidelines are promulgated. 

 (c) MONITORING. -- The Administrator shall, as part of each performance standard 

promulgated pursuant to subsection (a) and Section 111, promulgate regulations requiring the 

owner or operator of each solid waste incineration unit 
H-4 

 (1) to monitor emissions from the unit at the point at which such emissions are emitted into the 

ambient air (or within the stack, combustion chamber or pollution control equipment, as 

appropriate) and at such other points as necessary to protect public health and the environment; 

 (2) to monitor such other parameters relating to the operation of the unit and its pollution 

control technology as the Administrator determines are appropriate; and 

 (3) to report the results of such monitoring. Such regulations shall contain provisions 

regarding the frequency of monitoring, test methods and procedures validated on solid waste 

incineration units, and the form and frequency of reports containing the results of monitoring and 

shall require that any monitoring reports or test results indicating an exceedance of any standard 

under this section shall be reported separately and in a manner that facilitates review for 

purposes of enforcement actions. Such regulations shall require that copies of the results of such 

monitoring be maintained on file at the facility concerned and that copies shall be made available 

for inspection and copying by interested members of the public during business hours. 

 (d) OPERATOR TRAINING. -- Not later than 24 months after the enactment of the Clean Air 

Act Amendments of 1990, the Administrator shall develop and promote a model State program 

for the training and certification of solid waste incineration unit operators and high-capacity 

fossil fuel fired plant operators. The Administrator may authorize any State to implement a 

model program for the training of solid waste incineration unit operators and high-capacity fossil 

fuel fired plant operators, if the State has adopted a program which is at least as effective as the 

model program developed by the Administrator. Beginning on the date 36 months after the date 

on which performance standards and guidelines are promulgated under subsection (a) and 

Section 111 for any category of solid waste incineration units it shall be unlawful to operate any 

unit in the category unless each person with control over processes affecting emissions from 

such unit has satisfactorily completed a training program meeting the requirements established 

by the Administrator under this subsection. 

 (e) PERMITS. -- Beginning (1) 36 months after the promulgation of a performance standard 

under subsection (a) and Section 111 applicable to a category of solid waste incineration units, 

or (2) the effective date of a permit program under title V in the State in which the unit is 

located, whichever is later, each unit in the category shall operate pursuant to a permit issued 

under this subsection and title V. Permits required by this subsection may be renewed according 

to the provisions of title V. Notwithstanding any other provision of this Act, each permit for a 

solid waste incineration unit combusting municipal waste issued under this Act shall be issued 

for a period of up to 12 years and shall be reviewed every 5 years after date of issuance or 

reissuance. Each permit shall continue in effect after the date of issuance until the date of 

termination, unless the Administrator or State determines that the unit is not in compliance with 

all standards and conditions contained in the permit. Such determination shall be made at 

regular intervals during the term of the permit, such intervals not to exceed 5 years, and only 

after public comment and public hearing. No permit for a solid waste incineration unit may be 

issued under this Act by an agency, instrumentality or person that is also responsible, in whole or 

part, for the design and construction or operation of the unit. Notwithstanding any other 

provision of this subsection, the Administrator or the State shall require the owner or operator of 

any unit to comply with emissions limitations or implement any other measures, if the 

Administrator or the State determines that emissions in the absence of such limitations or 

measures my reasonably be anticipated to endanger public health or the environment. The 

Administrator's determination under the preceding sentence is a discretionary decision. 

 (f) EFFECTIVE DATE AND ENFORCEMENT. 
H-5 

 (1) NEW UNITS. -- Performance standards and other requirements promulgated pursuant to 

this section and Section 111 and applicable to new solid waste incineration units shall be 

effective as of the date 6 months after the date of promulgation. 

 (2) EXISTING UNITS. -- Performance standards and other requirements promulgated 

pursuant to this section and Section 111 and applicable to existing solid waste incineration units 

shall be effective as expeditiously as practicable after approval of a State plan under subsection 

(b)(2) (or promulgation of a plan by the Administrator under subsection (b)(3)) but in no event 

later than 3 years after the State plan is approved or 5 years after the date such standards or 

requirements are promulgated, whichever is earlier. 

 (3) PROHIBITION. -- After the effective date of any performance standard, emission 

limitation or other requirement promulgated pursuant to this section and Section 111, it shall be 

unlawful for any owner or operator of any solid waste incineration unit to which such standard, 

limitation or requirement applies to operate such unit in violation of such limitation, standard or 

requirement or for any other person to violate an applicable requirement of this section. 

 (4) COORDINATION WITH OTHER AUTHORITIES. -- For purposes of sections 111(e), 

113, 114, 116, 120, 303, 304, 307 and other provisions for the enforcement of this Act, each 

performance standard, emission limitation or other requirement established pursuant to this 

section by the Administrator or a State or local government, shall be treated in the same manner 

as a standard of performance under Section 111 which is an emission limitation. 

 (g) DEFINITIONS. -- For purposes of Section 306 of the Clean Air Act Amendments of 1990 

and this section only 

 (1) SOLID WASTE INCINERATION UNIT. -- The term 'solid waste incineration unit' means 

a distinct operating unit of any facility which combusts any solid waste material from 

commercial or industrial establishments or the general public (including single and multiple 

residences, hotels, and motels). Such term does not include incinerators or other units required 

to have a permit under Section 3005 of the Solid Waste Disposal Act. The term 'solid waste 

incineration unit' does not include (A) materials recovery facilities (including primary or 

secondary smelters) which combust waste for the primary purpose of recovering metals, (B) 

qualifying small power production facilities, as defined in Section 3(17)(C) of the Federal Power 

Act (16 U.S.C. 769(17)(C)), or qualifying cogeneration facilities, as defined in section 3(18)(B) 

of the Federal Power Act (16 U.S.C. 796(18)(B)), which burn homogeneous waste (such as units 

which burn tires or used oil, but not including refuse-derived fuel) for the production of electric 

energy or in the case of qualifying cogeneration facilities which burn homogeneous waste for the 

production of electric energy and steam or forms of useful energy (such as heat) which are used 

for industrial, commercial, heating or cooling purposes, or (C) air curtain incinerators provided 

that such incinerators only burn wood wastes, yard wastes and clean lumber and that such air 

curtain incinerators comply with opacity limitations to be established by the Administrator by 

rule. 

 (2) NEW SOLID WASTE INCINERATION UNIT. -- The term 'new solid waste incineration 

unit' means a solid waste incineration unit the construction of which is commenced after the 

Administrator proposes requirements under this section establishing emissions standards or 

other requirements which would be applicable to such unit or a modified solid waste incineration 

unit. 

 (3) MODIFIED SOLID WASTE INCINERATION UNIT. -- The term 'modified solid waste 

incineration unit' means a solid waste incineration unit at which modifications have occurred 

after the effective date of a standard under subsection (a) if (A) the cumulative cost of the 

modifications, over the life of the unit, exceed 50 per centum of the original cost of construction 
H-6 

and installation of the unit (not including the cost of any land purchased in connection with such 

construction or installation) updated to current costs, or (B) the modification is a physical change 

in or change in the method of operation of the unit which increases the amount of any air 

pollutant emitted by the unit for which standards have been established under this section or 

Section 111. 

 (4) EXISTING SOLID WASTE INCINERATION UNIT. -- The term 'existing solid waste 

incineration unit' means a solid waste unit which is not a new or modified solid waste 

incineration unit. 

 (5) MUNICIPAL WASTE. -- The term 'municipal waste' means refuse (and refuse-derived 

fuel) collected from the general public and from residential, commercial, institutional, and 

industrial sources consisting of paper, wood, yard wastes, food wastes, plastics, leather, rubber, 

and other combustible materials and non-combustible materials such as metal, glass and rock, 

provided that: (A) the term does not include industrial process wastes or medical wastes that are 

segregated from such other wastes; and (B) an incineration unit shall not be considered to be 

combusting municipal waste for purposes of Section 111 or this section if it combusts a fuel feed 

stream, 30 percent or less of the weight of which is comprised, in aggregate, of municipal waste. 

 (6) OTHER TERMS. -- The terms 'solid waste' and 'medical waste' shall have the meanings 

established by the Administrator pursuant to the Solid Waste Disposal Act. 

 (h) OTHER AUTHORITY. 

 (1) STATE AUTHORITY. -- Nothing in this section shall preclude or deny the right of any 

State or political subdivision thereof to adopt or enforce any regulation, requirement, limitation 

or standard relating to solid waste incineration units that is more stringent than a regulation, 

requirement, limitation or standard in effect under this section or under any other provision of 

this Act. 

 (2) OTHER AUTHORITY UNDER THIS ACT. -- Nothing in this section shall diminish the 

authority of the Administrator or a State to establish any other requirements applicable to solid 

waste incineration units under any other authority of law, including the authority to establish for 

any air pollutant a national ambient air quality standard, except that no solid waste incineration 

unit subject to performance standards under this section and Section 111 shall be subject to 

standards under Section 112(d) of this Act. 

 (3) RESIDUAL RISK. -- The Administrator shall promulgate standards under Section 112(f) 

for a category of solid waste incineration units, if promulgation of such standards is required 

under Section 112(f). For purposes of this preceding sentence only 

 (A) the performance standards under subsection (a) and Section 111 applicable to a category of 

solid waste incineration units shall be deemed standards under Section 112(d)(2), and 

 (B) the Administrator shall consider and regulate, if required, the pollutants listed under 

subsection (a)(4) and no others. 

 (4) ACID RAIN. -- A solid waste incineration unit shall not be utility unit as defined in title 

IV: provided, that, more than 80 per centum of its annual average fuel consumption measured on 

a Btu basis, during a period or periods to be determined by the Administrator, is from a fuel 

(including any waste burned as a fuel) other than a fossil fuel. 

 (5) REQUIREMENTS OF PARTS C AND D. -- No requirement of an applicable 

implementation plan under Section 165 (relating to construction of facilities in regions identified 

pursuant to Section 107(d)(1)(A)(ii) or (iii)) or under Section 172(c)(5) (relating to permits for 

construction and operation in nonattainment areas) may be used to weaken the standards in effect 

under this section. 
H-7 

---- ---- ---- 

 (b) CONFORMING AMENDMENT. -- Section 169(1) of the Clean Air Act is amended by 

striking "two hundred and" after "municipal incinerators capable of charging more than". 

 (c) REVIEW OF ACID GAS SCRUBBING REQUIREMENTS. -- Prior to the promulgation 

of any performance standard for solid waste incineration units combusting municipal waste 

under Section 111 or Section 129 of the Clean Air Act, the Administrator shall review the 

availability of acid gas scrubbers as a pollution control technology for small new units and for 

existing units (as defined in 54 Federal Register 52190 (December 20, 1989), taking into account 

the provisions of subsection (a)(2) of Section 129 of the Clean Air Act. 

Appendix I 

40 CFR Part 60 Subpart B
I-2 

APPENDIX I--40 CFR PART 60 SUBPART B 

Note: CFR text for 40 CFR Part 60 subpart B accessed Apr. 22, 2010 at e-CFR web site: 

http://ecfr.gpoaccess.gov. 

Subpart B -- Adoption and Submittal of State Plans for Designated Facilities 

Source: 40 FR 53346, Nov. 17, 1975, unless otherwise noted 

§ 60.20 Applicability. 

 The provisions of this subpart apply to States upon publication of a final guideline document 

under Section 60.22(a). 

§ 60.21 Definitions. 

 Terms used but not defined in this subpart shall have the meaning given them in the Act 

and in subpart A: 

 (a) Designated pollutant means any air pollutant, the emissions of which are subject to a 

standard of performance for new stationary sources, but for which air quality criteria have not 

been issued and that is not included on a list published under section 108(a) of the Act. 

Designated pollutant also means any air pollutant, the emissions of which are subject to a 

standard of performance for new stationary sources, that is on the section 112(b)(1) list and is 

emitted from a facility that is not part of a source category regulated under section 112. 

Designated pollutant does not include pollutants on the section 112(b)(1) list that are emitted 

from a facility that is part of a source category regulated under section 112. 

 (b) Designated facility means any existing facility (see §60.2(aa)) which emits a 

designated pollutant and which would be subject to a standard of performance for that pollutant 

if the existing facility were an affected facility (see §60.2(e)). 

 (c) Plan means a plan under section 111(d) of the Act which establishes emission 

standards for designated pollutants from designated facilities and provides for the 

implementation and enforcement of such emission standards. 

 (d) Applicable plan means the plan, or most recent revision thereof, which has been 

approved under §60.27(b) or promulgated under §60.27(d). 

 (e) Emission guideline means a guideline set forth in subpart C of this part, or in a final 

guideline document published under §60.22(a), which reflects the degree of emission reduction 

achievable through the application of the best system of emission reduction which (taking into 

account the cost of such reduction) the Administrator has determined has been adequately 

demonstrated for designated facilities. 

 (f) Emission standard means a legally enforceable regulation setting forth an allowable 

rate of emissions into the atmosphere, establishing an allowance system, or prescribing 

equipment specifications for control of air pollution emissions. 

 (g) Compliance schedule means a legally enforceable schedule specifying a date or dates 

by which a source or category of sources must comply with specific emission standards 

contained in a plan or with any increments of progress to achieve such compliance. 

 (h) Increments of progress means steps to achieve compliance which must be taken by an 

owner or operator of a designated facility, including: 

 (1) Submittal of a final control plan for the designated facility to the appropriate air 

pollution control agency; 
I-3 

 (2) Awarding of contracts for emission control systems or for process modifications, or 

issuance of orders for the purchase of component parts to accomplish emission control or process 

modification; 

 (3) Initiation of on-site construction or installation of emission control equipment or 

process change; 

 (4) Completion of on-site construction or installation of emission control equipment or 

process change; and 

 (5) Final compliance. 

 (i) Region means an air quality control region designated under section 107 of the Act 

and described in part 81 of this chapter. 

 (j) Local agency means any local governmental agency. 

 (k) Allowance system means a control program under which the owner or operator of 

each designated facility is required to hold an authorization for each specified unit of a 

designated pollutant emitted from that facility during a specified period and which limits the 

total amount of such authorizations available to be held for a designated pollutant for a specified 

period and allows the transfer of such authorizations not used to meet the authorization-holding 

requirement. 

[40 FR 53346, Nov. 17, 1975, as amended at 70 FR 28649, May 18, 2005] 

§ 60.22 Publication of guideline documents, emission guidelines, and final compliance times. 

 (a) Concurrently upon or after proposal of standards of performance for the control of a 

designated pollutant from affected facilities, the Administrator will publish a draft guideline 

document containing information pertinent to control of the designated pollutant form designated 

facilities. Notice of the availability of the draft guideline document will be published in the 

Federal Register and public comments on its contents will be invited. After consideration of 

public comments and upon or after promulgation of standards of performance for control of a 

designated pollutant from affected facilities, a final guideline document will be published and 

notice of its availability will be published in the Federal Register. 

 (b) Guideline documents published under this section will provide information for the 

development of State plans, such as: 

 (1) Information concerning known or suspected endangerment of public health or welfare 

caused, or contributed to, by the designated pollutant. 

 (2) A description of systems of emission reduction which, in the judgment of the 

Administrator, have been adequately demonstrated. 

 (3) Information on the degree of emission reduction which is achievable with each 

system, together with information on the costs and environmental effects of applying each 

system to designated facilities. 

 (4) Incremental periods of time normally expected to be necessary for the design, 

installation, and startup of identified control systems. 

 (5) An emission guideline that reflects the application of the best system of emission 

reduction (considering the cost of such reduction) that has been adequately demonstrated for 

designated facilities, and the time within which compliance with emission standards of 

equivalent stringency can be achieved. The Administrator will specify different emission 

guidelines or compliance times or both for different sizes, types, and classes of designated 

facilities when costs of control, physical limitations, geographical location, or similar factors 

make subcategorization appropriate. (6) Such other available information as the Administrator 

determines may contribute to the formulation of State plans. 
I-4 

 (c) Except as provided in paragraph (d)(1) of this section, the emission guidelines and 

compliance times referred to in paragraph (b)(5) of this section will be proposed for comment 

upon publication of the draft guideline document, and after consideration of comments will be 

promulgated in subpart C of this part with such modifications as may be appropriate. 

 (d)(1) If the Administrator determines that a designated pollutant may cause or contribute 

to endangerment of public welfare, but that adverse effects on public health have not been 

demonstrated, he will include the determination in the draft guideline document and in the 

Federal Register notice of its availability. Except as provided in paragraph (d)(2) of this section, 

paragraph (c) of this section shall be inapplicable in such cases. 

 (2) If the Administrator determines at any time on the basis of new information that a 

prior determination under paragraph (d)(1) of this section is incorrect or no longer correct, he 

will publish notice of the determination in the Federal Register, revise the guideline document as 

necessary under paragraph (a) of this section, and propose and promulgate emission guidelines 

and compliance times under paragraph (c) of this section. 

[40 FR 53346, Nov. 17, 1975, as amended at 54 FR 52189, Dec. 20, 1989] 

§ 60.23 Adoption and submittal of State plans; public hearings. 

 (a)(1) Unless otherwise specified in the applicable subpart, within 9 months after notice 

of the availability of a final guideline document is published under §60.22(a), each State shall 

adopt and submit to the Administrator, in accordance with §60.4 of subpart A of this part, a plan 

for the control of the designated pollutant to which the guideline document applies. 

 (2) Within nine months after notice of the availability of a final revised guideline 

document is published as provided in §60.22(d)(2), each State shall adopt and submit to the 

Administrator any plan revision necessary to meet the requirements of this subpart. 

 (b) If no designated facility is located within a State, the State shall submit a letter of 

certification to that effect to the Administrator within the time specified in paragraph (a) of this 

section. Such certification shall exempt the State from the requirements of this subpart for that 

designated pollutant. 

 (c)(1) Except as provided in paragraphs (c)(2) and (c)(3) of this section, the State shall, 

prior to the adoption of any plan or revision thereof, conduct one or more public hearings within 

the State on such plan or plan revision. 

 (2) No hearing shall be required for any change to an increment of progress in an 

approved compliance schedule unless the change is likely to cause the facility to be unable to 

comply with the final compliance date in the schedule. 

 (3) No hearing shall be required on an emission standard in effect prior to the effective 

date of this subpart if it was adopted after a public hearing and is at least as stringent as the 

corresponding emission guideline specified in the applicable guideline document published 

under §60.22(a). 

 (d) Any hearing required by paragraph (c) of this section shall be held only after 

reasonable notice. Notice shall be given at least 30 days prior to the date of such hearing and 

shall include: 

 (1) Notification to the public by prominently advertising the date, time, and place of such 

hearing in each region affected; 

 (2) Availability, at the time of public announcement, of each proposed plan or revision 

thereof for public inspection in at least one location in each region to which it will apply; 

 (3) Notification to the Administrator; 
I-5 

 (4) Notification to each local air pollution control agency in each region to which the 

plan or revision will apply; and 

 (5) In the case of an interstate region, notification to any other State included in the 

region. 

 (e) The State shall prepare and retain, for a minimum of 2 years, a record of each hearing 

for inspection by any interested party. The record shall contain, as a minimum, a list of witnesses 

together with the text of each presentation. 

 (f) The State shall submit with the plan or revision: 

 (1) Certification that each hearing required by paragraph (c) of this section was held in 

accordance with the notice required by paragraph (d) of this section; and 

 (2) A list of witnesses and their organizational affiliations, if any, appearing at the 

hearing and a brief written summary of each presentation or written submission. 

 (g) Upon written application by a State agency (through the appropriate Regional Office), 

the Administrator may approve State procedures designed to insure public participation in the 

matters for which hearings are required and public notification of the opportunity to participate 

if, in the judgment of the Administrator, the procedures, although different from the 

requirements of this subpart, in fact provide for adequate notice to and participation of the 

public. The Administrator may impose such conditions on his approval as he deems necessary. 

Procedures approved under this section shall be deemed to satisfy the requirements of this 

subpart regarding procedures for public hearings. 

[40 FR 53346, Nov. 17, 1975, as amended at 60 FR 65414, Dec. 19, 1995] 

§ 60.24 Emission standards and compliance schedules. 

 (a) Each plan shall include emission standards and compliance schedules. 

 (b)(1) Emission standards shall either be based on an allowance system or prescribe 

allowable rates of emissions except when it is clearly impracticable. 

 (2) Test methods and procedures for determining compliance with the emission standards 

shall be specified in the plan. Methods other than those specified in appendix A to this part may 

be specified in the plan if shown to be equivalent or alternative methods as defined in §60.2 (t) 

and (u). 

 (3) Emission standards shall apply to all designated facilities within the State. A plan 

may contain emission standards adopted by local jurisdictions provided that the standards are 

enforceable by the State. 

 (c) Except as provided in paragraph (f) of this section, where the Administrator has 

determined that a designated pollutant may cause or contribute to endangerment of public health, 

emission standards shall be no less stringent than the corresponding emission guideline(s) 

specified in subpart C of this part, and final compliance shall be required as expeditiously as 

practicable but no later than the compliance times specified in subpart C of this part. 

 (d) Where the Administrator has determined that a designated pollutant may cause or 

contribute to endangerment of public welfare but that adverse effects on public health have not 

been demonstrated, States may balance the emission guidelines, compliance times, and other 

information provided in the applicable guideline document against other factors of public 

concern in establishing emission standards, compliance schedules, and variances. Appropriate 

consideration shall be given to the factors specified in §60.22(b) and to information presented at 

the public hearing(s) conducted under §60.23(c). 

 (e)(1) Any compliance schedule extending more than 12 months from the date required 

for submittal of the plan must include legally enforceable increments of progress to achieve 
I-6 

compliance for each designated facility or category of facilities. Unless otherwise specified in 

the applicable subpart, increments of progress must include, where practicable, each increment 

of progress specified in §60.21(h) and must include such additional increments of progress as 

may be necessary to permit close and effective supervision of progress toward final compliance. 

 (2) A plan may provide that compliance schedules for individual sources or categories of 

sources will be formulated after plan submittal. Any such schedule shall be the subject of a 

public hearing held according to §60.23 and shall be submitted to the Administrator within 60 

days after the date of adoption of the schedule but in no case later than the date prescribed for 

submittal of the first semiannual report required by §60.25(e). 

 (f) Unless otherwise specified in the applicable subpart on a case-by-case basis for 

particular designated facilities or classes of facilities, States may provide for the application of 

less stringent emissions standards or longer compliance schedules than those otherwise required 

by paragraph (c) of this section, provided that the State demonstrates with respect to each such 

facility (or class of facilities): 

 (1) Unreasonable cost of control resulting from plant age, location, or basic process 

design; 

 (2) Physical impossibility of installing necessary control equipment; or 

 (3) Other factors specific to the facility (or class of facilities) that make application of a 

less stringent standard or final compliance time significantly more reasonable. 

 (g) Nothing in this subpart shall be construed to preclude any State or political 

subdivision thereof from adopting or enforcing (1) emission standards more stringent than 

emission guidelines specified in subpart C of this part or in applicable guideline documents or 

(2) compliance schedules requiring final compliance at earlier times than those specified in 

subpart C or in applicable guideline documents. 

 (h) Each of the States identified in paragraph (h)(1) of this section shall be subject to the 

requirements of paragraphs (h)(2) through (7) of this section. 

 (1) Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, 

Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, 

Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, 

Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, 

Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, 

Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, 

and the District of Columbia shall each, and, if approved for treatment as a State under part 49 of 

this chapter, the Navajo Nation and the Ute Indian Tribe may each, submit a State plan meeting 

the requirements of paragraphs (h)(2) through (7) of this section and the other applicable 

requirements for a State plan under this subpart. 

 (2) The State's State plan under paragraph (h)(1) of this section must be submitted to the 

Administrator by no later than November 17, 2006. The State shall deliver five copies of the 

State plan to the appropriate Regional Office, with a letter giving notice of such action. 

 (3) The State's State plan under paragraph (h)(1) of this section shall contain emission 

standards and compliance schedules and demonstrate that they will result in compliance with the 

State's annual electrical generating unit (EGU) mercury (Hg) budget for the appropriate periods. 

The amount of the annual EGU Hg budget, in tons of Hg per year, shall be as follows, for the 

indicated State for the indicated period: 
I-7 

State 

Annual EGU Hg budget 

(tons) 

2010–2017 

2018 and 

thereafter 

Alaska 0.010 0.004

Alabama 1.289 0.509

Arkansas 0.516 0.204

Arizona 0.454 0.179

California 0.041 0.016

Colorado 0.706 0.279

Connecticut 0.053 0.021

Delaware 0.072 0.028

Florida 1.232 0.487

Georgia 1.227 0.484

Hawaii 0.024 0.009

Iowa 0.727 0.287

Illinois 1.594 0.629

Indiana 2.097 0.828

Kansas 0.723 0.285

Kentucky 1.525 0.602

Louisiana 0.601 0.237

Massachusetts 0.172 0.068

Maryland 0.490 0.193

Maine 0.001 0.001

Michigan 1.303 0.514

Minnesota 0.695 0.274

Missouri 1.393 0.550

Mississippi 0.291 0.115

Montana 0.377 0.149

Navajo Nation 0.600 0.237

North Carolina 1.133 0.447

North Dakota 1.564 0.617

Nebraska 0.421 0.166

New Hampshire 0.063 0.025

New Jersey 0.153 0.060

New Mexico 0.299 0.118

Nevada 0.285 0.112
I-8 

State 

Annual EGU Hg budget 

(tons) 

2010–2017 

2018 and 

thereafter 

New York 0.393 0.155

Ohio 2.056 0.812

Oklahoma 0.721 0.285

Oregon 0.076 0.030

Pennsylvania 1.779 0.702

South Carolina 0.580 0.229

South Dakota 0.072 0.029

Tennessee 0.944 0.373

Texas 4.656 1.838

Utah 0.506 0.200

Ute Indian Tribe 0.060 0.024

Virginia 0.592 0.234

Washington 0.198 0.078

Wisconsin 0.890 0.351

West Virginia 1.394 0.550

Wyoming 0.952 0.376

Total 38.000 15.000

 (4) Each State plan under paragraph (h)(1) of this section shall require EGUs to comply 

with the monitoring, record keeping, and reporting provisions of part 75 of this chapter with 

regard to Hg mass emissions. 

 (5) In addition to meeting the requirements of §60.26, each State plan under paragraph 

(h)(1) of this section must show that the State has legal authority to: 

 (i) Adopt emissions standards and compliance schedules necessary for attainment and 

maintenance of the State's relevant annual EGU Hg budget under paragraph (h)(3) of this 

section; and 

 (ii) Require owners or operators of EGUs in the State to meet the monitoring, record 

keeping, and reporting requirements described in paragraph (h)(4) of this section. 

 (6)(i) Notwithstanding the provisions of paragraphs (h)(3) and (5)(i) of this section, if a 

State adopts regulations substantively identical to subpart HHHH of this part (Hg Budget 

Trading Program), incorporates such subpart by reference into its regulations, or adopts 

regulations that differ substantively from such subpart only as set forth in paragraph (h)(6)(ii) of 

this section, then such allowance system in the State's State plan is automatically approved as 

meeting the requirements of paragraph (h)(3) of this section, provided that the State 

demonstrates that it has the legal authority to take such action and to implement its 

responsibilities under such regulations. Before January 1, 2009, a State's regulations shall be 

considered to be substantively identical to subpart HHHH of this part, or differing substantively 
I-9 

only as set forth in paragraph (h)(6)(ii) of this section, regardless of whether the State's 

regulations include the definition of “Biomass”, paragraph (3) of the definition of “Cogeneration 

unit”, and the second sentence of the definition of “Total energy input” in §60.4102 of this 

chapter promulgated on October 19, 2007, provided that the State timely submits to the 

Administrator a State plan that revises the State's regulations to include such provisions. 

Submission to the Administrator of a State plan that revises the State's regulations to include 

such provisions shall be considered timely if the submission is made by January 1, 2010. 

 (ii) If a State adopts an allowance system that differs substantively from subpart HHHH 

of this part only as follows, then the emissions trading program is approved as set forth in 

paragraph (h)(6)(i) of this section. 

 (A) The State may decline to adopt the allocation provisions set forth in §§60.4141 and 

60.4142 and may instead adopt any methodology for allocating Hg allowances. 

 (B) The State's methodology under paragraph (h)(6)(ii)(A) of this section must not allow 

the State to allocate Hg allowances for a year in excess of the amount in the State's annual EGU 

Hg budget for such year under paragraph (h)(3) of this section; 

 (C) The State's methodology under paragraph (h)(6)(ii)(A) of this section must require 

that, for EGUs commencing operation before January 1, 2001, the State will determine, and 

notify the Administrator of, each unit's allocation of Hg allowances by November 17, 2006 for 

2010, 2011, and 2012 and by October 31, 2009 and October 31 of each year thereafter for the 

fourth year after the year of the notification deadline; and 

 (D) The State's methodology under paragraph (h)(6)(ii)(A) of this section must require 

that, for EGUs commencing operation on or after January 1, 2001, the State will determine, and 

notify the Administrator of, each unit's allocation of Hg allowances by October 31 of the year for 

which the Hg allowances are allocated. 

 (7) If a State adopts an allowance system that differs substantively from subpart HHHH 

of this part, other than as set forth in paragraph (h)(6)(ii) of this section, then such allowance 

system is not automatically approved as set forth in paragraph (h)(6)(i) or (ii) of this section and 

will be reviewed by the Administrator for approvability in accordance with the other provisions 

of paragraphs (h)(2) through (5) of this section and the other applicable requirements for a State 

plan under this subpart, provided that the Hg allowances issued under such allowance system 

shall not, and the State plan under paragraph (h)(1) of this section shall state that such Hg 

allowances shall not, qualify as Hg allowances under any allowance system approved under 

paragraph (h)(6)(i) or (ii) of this section. 

 (8) The terms used in this paragraph (h) shall have the following meanings: 

Administrator means the Administrator of the United States Environmental Protection 

Agency or the Administrator's duly authorized representative. 

Allocate or allocation means, with regard to Hg allowances, the determination of the 

amount of Hg allowances to be initially credited to a source. 

Biomass means—(1) Any organic material grown for the purpose of being converted to 

energy; 

 (2) Any organic byproduct of agriculture that can be converted into energy; or 

 (3) Any material that can be converted into energy and is nonmerchantable for other 

purposes, that is segregated from other nonmerchantable material, and that is; 

 (i) A forest-related organic resource, including mill residues, precommercial thinnings, 

slash, brush, or byproduct from conversion of trees to merchantable material; or 
I-10 

 (ii) A wood material, including pallets, crates, dunnage, manufacturing and construction 

materials (other than pressure-treated, chemically-treated, or painted wood products), and 

landscape or right-of-way tree trimmings. 

Boiler means an enclosed fossil-or other fuel-fired combustion device used to produce 

heat and to transfer heat to recirculating water, steam, or other medium. 

Bottoming-cycle cogeneration unit means a cogeneration unit in which the energy input 

to the unit is first used to produce useful thermal energy and at least some of the reject heat from 

the useful thermal energy application or process is then used for electricity production. 

Coal means any solid fuel classified as anthracite, bituminous, subbituminous, or lignite 

by the American Society of Testing and Materials (ASTM) Standard Specification for 

Classification of Coals by Rank D388–77, 90, 91, 95, 98a, or 99 (Reapproved 2004)ε1 

(incorporated by reference, see §60.17). 

Coal-derived fuel means any fuel (whether in a solid, liquid, or gaseous state) produced 

by the mechanical, thermal, or chemical processing of coal. 

Coal-fired means combusting any amount of coal or coal-derived fuel, alone or in 

combination with any amount of any other fuel, during any year. 

Cogeneration unit means a stationary, coal-fired boiler or stationary, coal-fired 

combustion turbine: 

 (1) Having equipment used to produce electricity and useful thermal energy for 

industrial, commercial, heating, or cooling purposes through the sequential use of energy; and 

 (2) Producing during the 12-month period starting on the date the unit first produces 

electricity and during any calendar year after which the unit first produces electricity: 

 (i) For a topping-cycle cogeneration unit, 

 (A) Useful thermal energy not less than 5 percent of total energy output; and 

 (B) Useful power that, when added to one-half of useful thermal energy produced, is not 

less then 42.5 percent of total energy input, if useful thermal energy produced is 15 percent or 

more of total energy output, or not less than 45 percent of total energy input, if useful thermal 

energy produced is less than 15 percent of total energy output. 

 (ii) For a bottoming-cycle cogeneration unit, useful power not less than 45 percent of 

total energy input; 

 (3) Provided that the total energy input under paragraphs (2)(i)(B) and (2)(ii) of this 

definition shall equal the unit's total energy input from all fuel except biomass if the unit is a 

boiler. 

Combustion turbine means: 

 (1) An enclosed device comprising a compressor, a combustion, and a turbine and in 

which the flue gas resulting from the combustion of fuel in the combustion passes through the 

turbine, rotating the turbine; and 

 (2) If the enclosed device under paragraph (1) of this definition is combined cycle, any 

associated heat recovery steam generator and steam turbine. 

Commence operation means to have begun any mechanical, chemical, or electronic 

process, including, with regard to a unit, start-up of a unit's combustion chamber. 

Electric generating unit or EGU means: 

 (1)(i) Except as provided in paragraphs (2) and (3) of this definition, a stationary, coalfired boiler or stationary, coal-fired combustion turbine in the State serving at any time, since the 

later of November 15, 1990 or the start-up of the unit's combustion chamber, a generator with 

nameplate capacity of more than 25 megawatts electric (MWe) producing electricity for sale. 
I-11 

 (ii) If a stationary boiler or stationary combustion turbine that, under paragraph (1)(i) of 

this definition, is not an electric generating unit begins to combust coal or coal-derived fuel or to 

serve a generator with nameplate capacity of more than 25 MWe producing electricity for sale, 

the unit shall become an electric generating unit as provided in paragraph (1)(i) of this definition 

on the first date on which it both combusts coal or coal-derived fuel and serves such generator. 

 (2) A unit that meets the requirements set forth in paragraph (2)(i)(A) of this definition 

shall not be an electric generating unit: 

 (i)(A) A unit that is an electric generating unit under paragraph (1)(i) or (ii) of this 

definition: 

 (1) Qualifying as a cogeneration unit during the 12-month period starting on the date the 

unit first produces electricity and continuing to qualify as a cogeneration unit; and 

 (2) Not serving at any time, since the later of November 15, 1990 or the start-up of the 

unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe 

supplying in any calendar year more than one-third of the unit's potential electric output capacity 

or 219,000 megawatt-hours (MWh), whichever is greater, to any utility power distribution 

system for sale. 

 (B) If a unit qualifies as a cogeneration unit during the 12-month period starting on the 

date the unit first produces electricity and meets the requirements of paragraph (2)(i)(A) of this 

definition for at least one calendar year, but subsequently no longer meets all such requirements, 

the unit shall become an electric generating unit starting on the earlier of January 1 after the first 

calendar year during which the unit first no longer qualifies as a cogeneration unit or January 1 

after the first calendar year during which the unit no longer meets the requirements of paragraph 

(2)(i)(A)(2) of this definition. 

 (3) A “solid waste incineration unit” as defined in Clean Air Act section 129(g)(1) 

combusting “municipal waste” as defined in Clean Air Act section 129(g)(5) shall not be an 

electric generating unit if it is subject to one of the following rules: 

 (i) An EPA-approved State plan for implementing subpart Cb of part 60 of this chapter, 

“Emissions Guidelines and Compliance Times for Large Municipal Waste Combustors That Are 

Constructed On or Before September 20, 1994”; 

 (ii) Subpart Eb of part 60 of this chapter, “Standards of Performance for Large Municipal 

Waste Combustors for Which Construction is Commenced After September 20, 1994 or for 

Which Modification or Reconstruction is Commenced After June 19, 1996”; 

 (iii) Subpart AAAA of part 60 of this chapter, “Standards of Performance for Small 

Municipal Waste Combustors for Which Construction is Commenced After August 30, 1999 or 

for Which Modification or Reconstruction is Commenced After June 6, 2001”; 

 (iv) An EPA-approved State Plan for implementing subpart BBBB of part 60 of this 

chapter, “Emission Guidelines and Compliance Times for Small Municipal Waste Combustion 

Units Constructed On or Before August 30, 1999”; 

 (v) Subpart FFF of part 62 of this chapter, “Federal Plan Requirements for Large 

Municipal Waste Combustors Constructed On or Before September 20, 1994; or 

 (vi) Subpart JJJ of 40 CFR part 62, “Federal Plan Requirements for Small Municipal 

Waste Combustion Units Constructed On or Before August 30, 1999”. 

Generator means a device that produces electricity. 

Gross electrical output means, with regard to a cogeneration unit, electricity made 

available for use, including any such electricity used in the power production process (which 

process includes, but is not limited to, any on-site processing or treatment of fuel combusted at 

the unit and any on-site emission controls). 
I-12 

Gross thermal energy means, with regard to a cogeneration unit, useful thermal energy 

output plus, where such output is made available for an industrial or commercial process, any 

heat contained in condensate return or makeup water. 

Heat input means, with regard to a specified period of time, the product (in million 

British thermal units per unit time, MMBTU/time) of the gross calorific value of the fuel (in Btu 

per pound, Btu/lb) divided by 1,000,000 Btu/MMBTU and multiplied by the fuel feed rate into a 

combustion device (in lb of fuel/time), as measured, recorded, and reported to the Administrator 

by the Hg designated representative and determined by the Administrator in accordance with 

§§60.4170 through 60.4176 and excluding the heat derived from preheated combustion air, 

reticulated flue gases, or exhaust from other sources. 

Hg allowance means a limited authorization issued by the permitting authority to emit 

one ounce of Hg during a control period of the specified calendar year for which the 

authorization is allocated or of any calendar year thereafter. 

Life-of-the-unit, firm power contractual arrangement means a unit participation power 

sales agreement under which a customer reserves, or is entitled to receive, a specified amount or 

percentage of nameplate capacity and associated energy generated by any specified unit and pays 

its proportional amount of such unit's total costs, pursuant to a contract: 

 (1) For the life of the unit; 

 (2) For a cumulative term of no less than 30 years, including contracts that permit an 

election for early termination; or 

 (3) For a period no less than 25 years or 70 percent of the economic useful life of the unit 

determined as of the time the unit is built, with option rights to purchase or release some portion 

of the nameplate capacity and associated energy generated by the unit at the end of the period. 

Maximum design heat input means, starting from the initial installation of a unit, the 

maximum amount of fuel per hour (in Btu/hr) that a unit is capable of combusting on a steadystate basis as specified by the manufacturer of the unit, or, starting from the completion of any 

subsequent physical change in the unit resulting in a decrease in the maximum amount of fuel 

per hour (in Btu per hour, Btu/hr) that a unit is capable of combusting on a steady-state basis, 

such decreased maximum amount as specified by the person conducting the physical change. 

Nameplate capacity means, starting from the initial installation of a generator, the 

maximum electrical generating output (in MW) that the generator is capable of producing on a 

steady-state basis and during continuous operation (when not restricted by seasonal or other 

derates) as specified by the manufacturer of the generator or, starting from the completion of any 

subsequent physical change in the generator resulting in an increase in the maximum electrical 

generating output (in MW) that the generator is capable of producing on a steady-state basis and 

during continuous operation (when not restricted by seasonal or other derates), such increased 

maximum amount as specified by the person conducting the physical change. 

Operator means any person who operates, controls, or supervises an EGU or a source that 

includes an EGU and shall include, but not be limited to, any holding company, utility system, or 

plant manager of such EGU or source. 

Ounce means 2.84 × 107 micrograms. 

Owner means any of the following persons: 

 (1) With regard to a Hg Budget source or a Hg Budget unit at a source, respectively: 

 (i) Any holder of any portion of the legal or equitable title in a Hg Budget unit at the 

source or the Hg Budget unit; 

 (ii) Any holder of a leasehold interest in a Hg Budget unit at the source or the Hg Budget 

unit; or 
I-13 

 (iii) Any purchaser of power from a Hg Budget unit at the source or the Hg Budget unit 

under a life-of-the-unit, firm power contractual arrangement; provided that, unless expressly 

provided for in a leasehold agreement, owner shall not include a passive lessor, or a person who 

has an equitable interest through such lessor, whose rental payments are not based (either 

directly or indirectly) on the revenues or income from such Hg Budget unit; or 

 (2) With regard to any general account, any person who has an ownership interest with 

respect to the Hg allowances held in the general account and who is subject to the binding 

agreement for the Hg authorized account representative to represent the person's ownership 

interest with respect to Hg allowances. 

Potential electrical output capacity means 33 percent of a unit's maximum design heat 

input, divided by 3,413 Btu per kilowatt-hour (Btu/kWh), divided by 1,000 kWh per megawatthour (kWh/MWh), and multiplied by 8,760 hr/yr. 

Sequential use of energy means: 

 (1) For a topping-cycle cogeneration unit, the use of reject heat from electricity 

production in a useful thermal energy application or process; or 

 (2) For a bottoming-cycle cogeneration unit, the use of reject heat from useful thermal 

energy application or process in electricity production. 

Source means all buildings, structures, or installations located in one or more contiguous 

or adjacent properties under common control of the same person or persons. 

State means: 

 (1) For purposes of referring to a governing entity, one of the States in the United States, 

the District of Columbia, or, if approved for treatment as a State under part 49 of this chapter, the 

Navajo Nation or Ute Indian Tribe that adopts the Hg Budget Trading Program pursuant to 

§60.24(h)(6); or 

 (2) For purposes of referring to a geographic area, one of the States in the United States, 

the District of Columbia, the Navajo Nation Indian country, or the Ute Tribe Indian country. 

Topping-cycle cogeneration unit means a cogeneration unit in which the energy input to 

the unit is first used to produce useful power, including electricity, and at least some of the reject 

heat from the electricity production is then used to provide useful thermal energy. 

Total energy input means, with regard to a cogeneration unit, total energy of all forms 

supplied to the cogeneration unit, excluding energy produced by the cogeneration unit itself. 

Each form of energy supplied shall be measured by the lower heating value of that form of 

energy calculated as follows: 

LHV = HHV − 10.55(W + 9H) 

Where: 

LHV = lower heating value of fuel in Btu/lb, 

HHV = higher heating value of fuel in Btu/lb, 

W = Weight % of moisture in fuel, and 

H = Weight % of hydrogen in fuel. 

Total energy output means, with regard to a cogeneration unit, the sum of useful power 

and useful thermal energy produced by the cogeneration unit. 

Unit means a stationary coal-fired boiler or a stationary coal-fired combustion turbine. 

Useful power means, with regard to a cogeneration unit, electricity or mechanical energy 

made available for use, excluding any such energy used in the power production process (which 
I-14 

process includes, but is not limited to, any on-site processing or treatment of fuel combusted at 

the unit and any on-site emission controls). 

Useful thermal energy means, with regard to a cogeneration unit, thermal energy that is: 

 (1) Made available to an industrial or commercial process (not a power production 

process), excluding any heat contained in condensate return or makeup water; 

 (2) Used in a heat application ( e.g. , space heating or domestic hot water heating); or 

 (3) Used in a space cooling application ( i.e. , thermal energy used by an absorption 

chiller). 

Utility power distribution system means the portion of an electricity grid owned or 

operated by a utility and dedicated to delivering electricity to customers. 

[40 FR 53346, Nov. 17, 1975, as amended at 60 FR 65414, Dec. 19, 1995; 65 FR 76384, Dec. 6, 

2000; 70 FR 28649, May 18, 2005; 71 FR 33398, June 9, 2006; 72 FR 59204, Oct. 19, 2007] 

§ 60.25 Emission inventories, source surveillance, reports. 

 (a) Each plan shall include an inventory of all designated facilities, including emission 

data for the designated pollutants and information related to emissions as specified in appendix 

D to this part. Such data shall be summarized in the plan, and emission rates of designated 

pollutants from designated facilities shall be correlated with applicable emission standards. As 

used in this subpart, “correlated” means presented in such a manner as to show the relationship 

between measured or estimated amounts of emissions and the amounts of such emissions 

allowable under applicable emission standards. 

 (b) Each plan shall provide for monitoring the status of compliance with applicable 

emission standards. Each plan shall, as a minimum, provide for: 

 (1) Legally enforceable procedures for requiring owners or operators of designated 

facilities to maintain records and periodically report to the State information on the nature and 

amount of emissions from such facilities, and/or such other information as may be necessary to 

enable the State to determine whether such facilities are in compliance with applicable portions 

of the plan. Submission of electronic documents shall comply with the requirements of 40 CFR 

part 3—(Electronic reporting). 

 (2) Periodic inspection and, when applicable, testing of designated facilities. 

 (c) Each plan shall provide that information obtained by the State under paragraph (b) of 

this section shall be correlated with applicable emission standards (see §60.25(a)) and made 

available to the general public. 

 (d) The provisions referred to in paragraphs (b) and (c) of this section shall be 

specifically identified. Copies of such provisions shall be submitted with the plan unless: 

 (1) They have been approved as portions of a preceding plan submitted under this subpart 

or as portions of an implementation plan submitted under section 110 of the Act, and 

 (2) The State demonstrates: 

 (i) That the provisions are applicable to the designated pollutant(s) for which the plan is 

submitted, and 

 (ii) That the requirements of §60.26 are met. 

 (e) The State shall submit reports on progress in plan enforcement to the Administrator 

on an annual (calendar year) basis, commencing with the first full report period after approval of 

a plan or after promulgation of a plan by the Administrator. Information required under this 

paragraph must be included in the annual report required by §51.321 of this chapter. 

 (f) Each progress report shall include: 
I-15 

 (1) Enforcement actions initiated against designated facilities during the reporting period, 

under any emission standard or compliance schedule of the plan. 

 (2) Identification of the achievement of any increment of progress required by the 

applicable plan during the reporting period. 

 (3) Identification of designated facilities that have ceased operation during the reporting 

period. 

 (4) Submission of emission inventory data as described in paragraph (a) of this section 

for designated facilities that were not in operation at the time of plan development but began 

operation during the reporting period. 

 (5) Submission of additional data as necessary to update the information submitted under 

paragraph (a) of this section or in previous progress reports. 

 (6) Submission of copies of technical reports on all performance testing on designated 

facilities conducted under paragraph (b)(2) of this section, complete with concurrently recorded 

process data. 

[40 FR 53346, Nov. 17, 1975, as amended at 44 FR 65071, Nov. 9, 1979; 70 FR 59887, Oct. 13, 

2005] 

§ 60.26 Legal authority. 

 (a) Each plan shall show that the State has legal authority to carry out the plan, including 

authority to: 

 (1) Adopt emission standards and compliance schedules applicable to designated 

facilities. 

 (2) Enforce applicable laws, regulations, standards, and compliance schedules, and seek 

injunctive relief. 

 (3) Obtain information necessary to determine whether designated facilities are in 

compliance with applicable laws, regulations, standards, and compliance schedules, including 

authority to require recordkeeping and to make inspections and conduct tests of designated 

facilities. 

 (4) Require owners or operators of designated facilities to install, maintain, and use 

emission monitoring devices and to make periodic reports to the State on the nature and amounts 

of emissions from such facilities; also authority for the State to make such data available to the 

public as reported and as correlated with applicable emission standards. 

 (b) The provisions of law or regulations which the State determines provide the 

authorities required by this section shall be specifically identified. Copies of such laws or 

regulations shall be submitted with the plan unless: 

 (1) They have been approved as portions of a preceding plan submitted under this subpart 

or as portions of an implementation plan submitted under section 110 of the Act, and 

 (2) The State demonstrates that the laws or regulations are applicable to the designated 

pollutant(s) for which the plan is submitted. 

 (c) The plan shall show that the legal authorities specified in this section are available to 

the State at the time of submission of the plan. Legal authority adequate to meet the requirements 

of paragraphs (a)(3) and (4) of this section may be delegated to the State under section 114 of the 

Act. 

 (d) A State governmental agency other than the State air pollution control agency may be 

assigned responsibility for carrying out a portion of a plan if the plan demonstrates to the 

Administrator's satisfaction that the State governmental agency has the legal authority necessary 

to carry out that portion of the plan. 
I-16 

 (e) The State may authorize a local agency to carry out a plan, or portion thereof, within 

the local agency's jurisdiction if the plan demonstrates to the Administrator's satisfaction that the 

local agency has the legal authority necessary to implement the plan or portion thereof, and that 

the authorization does not relieve the State of responsibility under the Act for carrying out the 

plan or portion thereof. 

§ 60.27 Actions by the Administrator. 

 (a) The Administrator may, whenever he determines necessary, extend the period for 

submission of any plan or plan revision or portion thereof. 

 (b) After receipt of a plan or plan revision, the Administrator will propose the plan or 

revision for approval or disapproval. The Administrator will, within four months after the date 

required for submission of a plan or plan revision, approve or disapprove such plan or revision or 

each portion thereof. 

 (c) The Administrator will, after consideration of any State hearing record, promptly 

prepare and publish proposed regulations setting forth a plan, or portion thereof, for a State if: 

 (1) The State fails to submit a plan within the time prescribed; 

 (2) The State fails to submit a plan revision required by §60.23(a)(2) within the time 

prescribed; or 

 (3) The Administrator disapproves the State plan or plan revision or any portion thereof, 

as unsatisfactory because the requirements of this subpart have not been met. 

 (d) The Administrator will, within six months after the date required for submission of a 

plan or plan revision, promulgate the regulations proposed under paragraph (c) of this section 

with such modifications as may be appropriate unless, prior to such promulgation, the State has 

adopted and submitted a plan or plan revision which the Administrator determines to be 

approvable. 

 (e)(1) Except as provided in paragraph (e)(2) of this section, regulations proposed and 

promulgated by the Administrator under this section will prescribe emission standards of the 

same stringency as the corresponding emission guideline(s) specified in the final guideline 

document published under §60.22(a) and will require final compliance with such standards as 

expeditiously as practicable but no later than the times specified in the guideline document. 

 (2) Upon application by the owner or operator of a designated facility to which 

regulations proposed and promulgated under this section will apply, the Administrator may 

provide for the application of less stringent emission standards or longer compliance schedules 

than those otherwise required by this section in accordance with the criteria specified in 

§60.24(f). 

 (f) Prior to promulgation of a plan under paragraph (d) of this section, the Administrator 

will provide the opportunity for at least one public hearing in either: 

 (1) Each State that failed to hold a public hearing as required by §60.23(c); or 

 (2) Washington, DC or an alternate location specified in the Federal Register. 

[40 FR 53346, Nov. 17, 1975, as amended at 65 FR 76384, Dec. 6, 2000] 

§ 60.28 Plan revisions by the State. 

 (a) Plan revisions which have the effect of delaying compliance with applicable emission 

standards or increments of progress or of establishing less stringent emission standards shall be 

submitted to the Administrator within 60 days after adoption in accordance with the procedures 

and requirements applicable to development and submission of the original plan. 
I-17 

 (b) More stringent emission standards, or orders which have the effect of accelerating 

compliance, may be submitted to the Administrator as plan revisions in accordance with the 

procedures and requirements applicable to development and submission of the original plan. 

 (c) A revision of a plan, or any portion thereof, shall not be considered part of an 

applicable plan until approved by the Administrator in accordance with this subpart. 

§ 60.29 Plan revisions by the Administrator. 

 After notice and opportunity for public hearing in each affected State, the Administrator 

may revise any provision of an applicable plan if: 

 (a) The provision was promulgated by the Administrator, and 

 (b) The plan, as revised, will be consistent with the Act and with the requirements of this 

subpart. 

Appendix J 

40 CFR Part 62 Subpart A 
J-2 

APPENDIX J--40 CFR PART 62 SUBPART A 

Note: CFR text for 40 CFR Part 62 subpart A accessed Jul. 13, 2010 at e-CFR web site: 

http://ecfr.gpoaccess.gov. 

PART 62—APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED 

FACILITIES AND POLLUTANTS 

Subpart A—General Provisions 

§ 62.01 Definitions. 

 As used in this part, all terms not defined herein shall have the meaning given to them in 

the Clean Air Act and in part 60 of this chapter. 

§ 62.02 Introduction. 

 (a) This part sets forth the Administrator's approval and disapproval of State plans for the 

control of pollutants and facilities under section 111(d), and section 129 as applicable, of the 

Act, and the Administrator's promulgation of such plans or portions of plans thereof. Approval of 

a plan or any portion of a plan is based on a determination by the Administrator that it meets the 

requirements of section 111(d), and section 129 as applicable, of the Act and provisions of part 

60 of this chapter. 

 (b)(1) If a State does not submit a complete, approvable plan, the Administrator may then 

promulgate a substitute plan or part of a plan. The promulgated provision, plus the approved 

parts of the State plan, constitute the applicable plan for purposes of the act. 

 (2) The part 60 subpart A of this chapter general provisions and appendices to part 60 

apply to part 62, except as follows: 40 CFR 60.7(a)(1), 60.7(a)(3), and 60.8(a) and where special 

provisions set forth under the applicable subpart of this part shall apply instead of any conflicting 

provisions. 

 (c) The Administrator will promulgate substitute provisions for the disapproved 

regulatory provisions only. If a nonregulatory provision is disapproved, however, it will be noted 

in this part and a detailed explanation will be sent to the State. 

 (d) All approved regulatory provisions of each plan are incorporated by reference in this 

part. Section 62.12 provides information on availability of applicable plans. The Administrator 

and State and local agencies shall enforce (1) regulatory provisions of a plan approved or 

promulgated by the Administrator, and (2) all permit conditions or denials issued in carrying out 

the approved or promulgated regulations for the review of designated facilities. 

 (e) Each State's plan is dealt with in a separate subpart, with separate headings for 

different pollutants and facilities. The plans shall include an introductory section identifying the 

plan by name and the date of its submittal. Additional sections are included as necessary to 

specifically identify disapproved provisions, to set forth reasons for disapproval, and to set forth 

provisions of the plan promulgated by the Administrator. Except as otherwise specified, all 

supplemental information submitted to the Administrator with respect to any plan has been 

submitted by the Governor of the State. 

 (f) Revisions to applicable plans will be included in this part when approved or 

promulgated by the Administrator. 

 (g) Substitute plans promulgated by the Administrator for States that do not have 

approved plans are contained in separate subparts that appear after the subparts for States. These 
J-3 

Federal plans include sections identifying the applicability of the plan, emission limits, 

compliance schedules, recordkeeping and reporting, performance testing, and monitoring 

requirements. 

[43 FR 51393, Nov. 3, 1978, as amended at 63 FR 63201, Nov. 12, 1998; 68 FR 5158, Jan. 31, 

2003] 

§ 62.03 Extensions. 

 The Administrator may, whenever he determines necessary, extend the period for 

submission of any plan or plan revision or portion thereof. 

§ 62.04 Approval status. 

 The approval status of each State's plan or portions thereof, are set forth in each subpart. 

All plans are approved unless specifically disapproved in the appropriate subpart. 

§ 62.05 Legal authority. 

 (a) The Administrator's determination of the absence or inadequacy of legal authority 

required to be included in the plan is set forth in each subpart. This includes the legal authority 

of local agencies and State governmental agencies other than an air pollution control agency if 

such other agencies are assigned responsibility for carrying out a plan or portion thereof. 

 (b) No legal authority as such is promulgated by the Administrator. Where required 

regulatory provisions are not included in the plan by the State because of inadequate authority, 

substitute provisions are promulgated by the Administrator. 

§ 62.06 Negative declarations. 

 A State may submit to the Administrator a letter certifying that no designated facilities 

exist in the State if such is the case. The negative declaration will be in lieu of a plan. 

§ 62.07 Emission standards, compliance schedules. 

 (a) In each subpart, emission standards and compliance schedules which have been 

disapproved by the Administrator are identified, and those promulgated by the Administrator are 

set forth. 

 (b) The Administrator's approval or promulgation of any compliance schedule shall not 

affect the responsibility of the owner or operator to comply with any applicable emission 

limitation on or after the date for final compliance specified in the applicable schedule. 

§ 62.08 Emission inventories and source surveillance. 

 (a) Each subpart identifies the plan provisions for source surveillance which are 

disapproved, and sets forth the Administrator's promulgation of necessary provisions for 

requiring designated sources to maintain records, make reports, and submit information. 

 (b) The Administrator will not promulgate provisions for disapproved State or local 

agency procedures for testing, inspection, investigation, or detection. However, detailed critiques 

of such portions will be provided to the State. 

§ 62.09 Revision of plans by Administrator. 

 After notice and opportunity for public hearing in each affected State, the Administrator 

may revise any provision of an applicable plan if: 

 (a) The provision was promulgated by the Administrator and 
J-4 

 (b) The plan, as revised, will be consistent with the Act and with the requirements of part 

60, subpart B of this chapter. 

§ 62.10 Submission to Administrator. 

 Except as otherwise provided in §60.23 of this chapter, all requests, reports, applications, 

submittals, and other communications to the Administrator pursuant to this part shall be 

submitted in duplicate and addressed to the appropriate Regional Office of the Environmental 

Protection Agency, to the attention of the Director, Air and Hazardous Materials Division 

(Environmental Programs Division in Region II). The Regional Offices are as follows: 

Region and jurisdiction covered Address 

I—Connecticut, Maine, 

Massachusetts, New Hampshire, 

Rhode Island, Vermont 

JFK Federal Building, Boston, Mass. 02203. 

II—New York, New Jersey, Puerto 

Rico, Virgin Islands 

Federal Office Building, 26 Federal Plaza, New York, N.Y. 

10007. 

III—Delaware, District of 

Columbia, Maryland, 

Pennsylvania, Virginia, West 

Virginia 

Air Protection Division, Mail Code 3AP00, 1650 Arch 

Street, Philadelphia, PA 19103–1129. 

IV—Alabama, Florida, Georgia, 

Mississippi, Kentucky, North 

Carolina, South Carolina, 

Tennessee 

345 Courtland NE., Atlanta, Ga. 30308. 

V—Illinois, Indiana, Michigan, 

Minnesota, Ohio, Wisconsin 

Mail Code A–17J, 77 West Jackson Blvd., Chicago, Il 

60604–3590. 

VI—Arkansas, Louisiana, New 

Mexico, Oklahoma, Texas 

1st International Building, 1201 Elm St., Dallas, Tex. 

75270. 

VII—Iowa, Kansas, Missouri, 

Nebraska 

Air, RCRA, and Toxics Division, 901 N. 5th Street, Kansas 

City, KS 66101. 

VIII—Colorado, Montana, North 

Dakota, South Dakota, Utah, 

Wyoming 

Director, Air Program, Office of Partnerships and 

Regulatory Assistance, Mail Code 8P–AR, 1595 Wynkoop 

Street, Denver, CO 80202–1129. 

IX—Arizona, California, Hawaii, 

Nevada, Guam, American Samoa 

215 Fremont St., San Francisco, Calif. 94105. 

X—Washington, Oregon, Idaho, 

Alaska 

1200 6th Ave., Seattle, Wash. 98101. 

[43 FR 51393, Nov. 3, 1978, as amended at 62 FR 1834, Jan. 14, 1997; 68 FR 35729, June 17, 

2003; 73 FR 24871, May 6, 2008; 74 FR 66923, Dec. 17, 2009] 

§ 62.11 Severability. 

 The provisions promulgated in this part and the various applications thereof are distinct 

and severable. If any provision of this part or the application thereof to any person or 

circumstances is held invalid, such invalidity shall not affect other provisions or application of 

such provision to other persons or circumstances which can be given effect without the invalid 

provision or application. 
J-5 

§ 62.12 Availability of applicable plans. 

 Copies of the applicable plans will be available for public inspection at the following 

locations: 

 (a) The offices of the Directors, Air and Hazardous Materials Divisions at EPA Regional 

Offices I, III–X, and the Director, Environmental Programs Division at EPA Regional Office II. 

The addresses and jurisdictions covered by these appear in §62.10. 

 (b) Public Information Reference Unit, Library Systems Branch, EPA (PM 213), 401 M 

St., SW., Washington, DC 20460. 

§ 62.13 Federal plans. 

 The Federal plans apply to owners and operators of affected facilities that are not covered 

by an EPA approved and currently effective State or Tribal plan. This Federal plan, or portions 

thereof, also applies to each affected facility located in any State or portion of Indian country 

whose approved State or Tribal plan for that area is subsequently vacated in whole or in part. 

Affected facilities are defined in each Federal plan. 

 (a) The substantive requirements of the municipal waste combustor Federal plan are 

contained in subpart FFF of this part. These requirements include emission limits, compliance 

schedules, testing, monitoring, and reporting and recordkeeping requirements. 

 (b) The substantive requirements of the municipal solid waste landfills Federal plan are 

contained in subpart GGG of this part. These requirements include emission limits, compliance 

schedules, testing, monitoring, and reporting and recordkeeping requirements. 

 (c) The substantive requirements of the hospital/ medical/infectious waste incinerator 

Federal plan are contained in subpart HHH of this part. These requirements include emission 

limits, compliance schedules, testing, monitoring and reporting and recordkeeping requirements. 

 (d) The substantive requirements of the commercial and industrial solid waste 

incineration units Federal plan are contained in subpart III of this part. These requirements 

include emission limits, compliance schedules, testing, monitoring, and reporting and 

recordkeeping requirements. 

 (e) The substantive requirements of the small municipal waste combustion unit Federal 

plan are contained in subpart JJJ of this part. These requirements include emission limits, 

compliance schedules, testing, monitoring, and reporting and recordkeeping requirements. 

[63 FR 63201, Nov. 12, 1998, as amended at 65 FR 49881, Aug. 15, 2000; 68 FR 5158, Jan. 31, 

2003; 68 FR 57539, Oct. 3, 2003] 

Appendix K 

40 CFR Part 60 Subparts Ce (EG) and Ec (NSPS) 

K1 40 CFR Part 60 Subpart Ce 

K2 40 CFR Part 60 Subpart Ec
Appendix K1 

40 CFR Part 60 Subpart Ce
K-3 

APPENDIX K1--40 CFR PART 60 SUBPART Ce 

Note: CFR text for 40 CFR Part 60 subpart Ce accessed Apr. 30, 2010 at e-CFR web site: 

http://ecfr.gpoaccess.gov. 

Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste 

Incinerators 

Source: 62 FR 48379, Sept. 15, 1997, unless otherwise noted. 

§ 60.30e Scope. 

 This subpart contains emission guidelines and compliance times for the control of certain 

designated pollutants from hospital/medical/infectious waste incinerator(s) (HMIWI) in 

accordance with sections 111 and 129 of the Clean Air Act and subpart B of this part. The 

provisions in these emission guidelines supersede the provisions of §60.24(f) of subpart B of this 

part. 

§ 60.31e Definitions. 

 Terms used but not defined in this subpart have the meaning given them in the Clean Air 

Act and in subparts A, B, and Ec of this part. 

Standard Metropolitan Statistical Area or SMSA means any areas listed in OMB Bulletin 

No. 93–17 entitled “Revised Statistical Definitions for Metropolitan Areas” dated June 30, 1993 

(incorporated by reference, see §60.17). 

§ 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. 

 (b) A combustor is not subject to this subpart during periods when only pathological 

waste, low-level radioactive waste, and/or chemotherapeutic waste (all defined in §60.51c) is 

burned, provided the owner or operator of the combustor: 

 (1) Notifies the Administrator of an exemption claim; and 

 (2) Keeps records on a calendar quarter basis of the periods of time when only 

pathological waste, low-level radioactive waste, and/or chemotherapeutic waste is burned. 

 (c) Any co-fired combustor (defined in §60.51c) is not subject to this subpart if the owner 

60.32or operator of the co-fired combustor: 

 (1) Notifies the Administrator of an exemption claim; 

 (2) Provides an estimate of the relative weight of hospital waste, medical/infectious 

waste, and other fuels and/or wastes to be combusted; and 

 (3) Keeps records on a calendar quarter basis of the weight of hospital waste and 

medical/infectious waste combusted, and the weight of all other fuels and wastes combusted at 

the co-fired combustor. 

 (d) Any combustor required to have a permit under Section 3005 of the Solid Waste 

Disposal Act is not subject to this subpart. 
K-4 

 (e) Any combustor which meets the applicability requirements under subpart Cb, Ea, or 

Eb of this part (standards or guidelines for certain municipal waste combustors) is not subject to 

this subpart. 

 (f) Any pyrolysis unit (defined in §60.51c) is not subject to this subpart. 

 (g) Cement kilns firing hospital waste and/or medical/infectious waste are not subject to 

this subpart. 

 (h) Physical or operational changes made to an existing HMIWI unit solely for the 

purpose of complying with emission guidelines under this subpart are not considered a 

modification and do not result in an existing HMIWI unit becoming subject to the provisions of 

subpart Ec (see §60.50c). 

 (i) Beginning September 15, 2000, or on the effective date of an EPA approved operating 

permit program under Clean Air Act title V and the implementing regulations under 40 CFR part 

70 in the State in which the unit is located, whichever date is later, designated facilities subject to 

this subpart shall operate pursuant to a permit issued under the EPA-approved operating permit 

program. 

 (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 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. 

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51402, Oct. 6, 2009] 

§ 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. 
K-5 

 (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. 

[74 FR 51403, Oct. 6, 2009] 

§ 60.34e Operator training and qualification guidelines. 

 For approval, a State plan shall include the requirements for operator training and 

qualification at least as protective as those requirements listed in §60.53c of subpart Ec of this 

part. The State plan shall require compliance with these requirements according to the schedule 

specified in §60.39e(e). 

§ 60.35e Waste management guidelines. 

 For approval, a State plan shall include the requirements for a waste management plan at 

least as protective as those requirements listed in §60.55c of subpart Ec of this part. 

§ 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: 

 (1) At a minimum, an inspection shall include the following: 

 (i) Inspect all burners, pilot assemblies, and pilot sensing devices for proper operation; 

clean pilot flame sensor, as necessary; 

 (ii) Ensure proper adjustment of primary and secondary chamber combustion air, and 

adjust as necessary; 

 (iii) Inspect hinges and door latches, and lubricate as necessary; 

 (iv) Inspect dampers, fans, and blowers for proper operation; 

 (v) Inspect HMIWI door and door gaskets for proper sealing; 

 (vi) Inspect motors for proper operation; 

 (vii) Inspect primary chamber refractory lining; clean and repair/replace lining as 

necessary; 

 (viii) Inspect incinerator shell for corrosion and/or hot spots; 

 (ix) Inspect secondary/tertiary chamber and stack, clean as necessary; 

 (x) Inspect mechanical loader, including limit switches, for proper operation, if 

applicable; 

 (xi) Visually inspect waste bed (grates), and repair/seal, as appropriate; 

 (xii) For the burn cycle that follows the inspection, document that the incinerator is 

operating properly and make any necessary adjustments; 

 (xiii) Inspect air pollution control device(s) for proper operation, if applicable; 

 (xiv) Inspect waste heat boiler systems to ensure proper operation, if applicable; 

 (xv) Inspect bypass stack components; 
K-6 

 (xvi) Ensure proper calibration of thermocouples, sorbent feed systems and any other 

monitoring equipment; and 

 (xvii) Generally observe that the equipment is maintained in good operating condition. 

 (2) Within 10 operating days following an equipment inspection all necessary repairs 

shall be completed unless the owner or operator obtains written approval from the State agency 

establishing a date whereby all necessary repairs of the designated facility shall be completed. 

 (b) For approval, a State plan shall require 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. 

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51403, Oct. 6, 2009] 

§ 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). 
K-7 

 (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 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: 

 (1) Establish maximum charge rate and minimum secondary chamber temperature as sitespecific operating parameters during the initial performance test to determine compliance with 

applicable emission 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 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: 
K-8 

 (1) Install, calibrate (to manufacturers' specifications), maintain, and operate a device for 

measuring and recording the temperature of the secondary chamber on a continuous basis, the 

output of which shall be recorded, at a minimum, once every minute throughout operation. 

 (2) Install, calibrate (to manufacturers' specifications), maintain, and operate a device 

which automatically measures and records the date, time, and weight of each charge fed into the 

HMIWI. 

 (3) The owner or operator of a designated facility shall obtain monitoring data at all times 

during HMIWI operation except during periods of monitoring equipment malfunction, 

calibration, or repair. At a minimum, valid monitoring data shall be obtained for 75 percent of 

the operating hours per day 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. 

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51403, Oct. 6, 2009] 

§ 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 
K-9 

 (2) Submit an annual report containing information recorded under paragraph (b)(1) of 

this section no later than 60 days following the year in which data were collected. Subsequent 

reports shall be sent no later than 12 calendar months following the previous report (once the 

unit is subject to permitting requirements under Title V of the Act, the owner or operator must 

submit these reports semiannually). The report shall be signed by the facilities manager. 

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51404, Oct. 6, 2009] 

§ 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. 

 (b) Except as provided in paragraphs (c) and (d) of this section, State plans shall provide 

that designated facilities comply with all requirements of the State plan on or before the date 1 

year after EPA approval of the State plan, regardless of whether a designated facility is identified 

in the State plan inventory required by §60.25(a) of subpart B of this part. 

 (c) State plans that specify measurable and enforceable incremental steps of progress 

towards compliance for designated facilities planning to install the necessary air pollution 

control equipment may allow compliance on or before the date 3 years after EPA approval of the 

State plan (but not later than 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. 

 (2) Date for obtaining services of an architectural and engineering firm regarding the air 

pollution control device(s); 

 (3) Date for obtaining design drawings of the air pollution control device(s); 

 (4) Date for ordering the air pollution control device(s); 

 (5) Date for obtaining the major components of the air pollution control device(s); 

 (6) Date for initiation of site preparation for installation of the air pollution control 

device(s); 

 (7) Date for initiation of installation of the air pollution control device(s); 

 (8) Date for initial startup of the air pollution control device(s); and 

 (9) Date for initial compliance test(s) of the air pollution control device(s). 

 (d) State plans that include provisions allowing designated facilities to petition the State 

for extensions beyond the compliance times required in paragraph (b) of this section shall: 

 (1) Require that the designated facility requesting an extension submit the following 

information in time to allow the State adequate time to grant or deny the extension within 1 year 

after EPA approval of the State plan: 

 (i) Documentation of the analyses undertaken to support the need for an extension, 

including an explanation of why up to 3 years after EPA approval of the State plan is sufficient 

time to comply with the State plan while 1 year after EPA approval of the State plan is not 

sufficient. The documentation shall also include an evaluation of the option to transport the 
K-10 

waste offsite to a commercial medical waste treatment and disposal facility on a temporary or 

permanent basis; and 

 (ii) Documentation of measurable and enforceable incremental steps of progress to be 

taken towards compliance with the emission guidelines. 

 (2) Include procedures for granting or denying the extension; and 

 (3) If an extension is granted, require compliance with the 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. 

 (e) For approval, a State plan shall require compliance with §60.34e—Operator training 

and qualification guidelines and §60.36e—Inspection guidelines by the date 1 year after EPA 

approval of a State plan. 

 (f) The Administrator shall develop, implement, and enforce a plan for existing HMIWI 

located in any State that has not submitted an approvable plan within 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. 

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51404, Oct. 6, 2009] 

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 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

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 

EPA Reference Method 

26 or 26A of appendix 

A–8 of part 60. 
K-11 

Pollutant 

Units 

(7 percent oxygen, dry 

basis) 

Emissions limits 

Averaging 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

Small Medium Large 

per run) 

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. 

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

1

Except 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). 

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51405, Oct. 6, 2009] 

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 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

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. 
K-12 

Pollutant 

Units 

(7 percent oxygen, dry 

basis) 

Emissions limits 

Averaging 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

Small Medium Large 

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/103dscf) 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. 

Mercury mg/dscm (gr/103dscf) 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. 

1

Except 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). 

[74 FR 51406, Oct. 6, 2009] 

Table 2A to Subpart Ceof 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 time1

Method for demonstrating 

compliance2

Particulate mg/dscm (gr/dscf) 197 (0.086) 3-run average (1- EPA Reference Method 5 of 
K-13 

Pollutant 

Units 

(7 percent oxygen, dry 

basis) 

HMIWI 

emissions 

limits Averaging time1

Method for demonstrating 

compliance2

matter hour minimum 

sample time per 

run) 

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/103dscf) 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/103dscf) 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/103dscf) 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. 

1

Except 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). 

[74 FR 51407, Oct. 6, 2009] 

Table 2B to Subpart Ceof 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 time1

Method for demonstrating 

compliance2

Particulate 

matter 

mg/dscm (gr/dscf) 87 (0.038) 3-run average (1-

hour minimum 

sample time per 

EPA Reference Method 5 of 

appendix A–3 of part 60, or EPA 

Reference Method 26A or 29 of 
K-14 

Pollutant 

Units 

(7 percent oxygen, dry 

basis) 

HMIWI 

Emissions 

limits Averaging time1

Method for demonstrating 

compliance2

run) 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. 

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/103dscf) 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/103dscf) 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/103dscf) 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. 

1

Except 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). 

[74 FR 51407, Oct. 6, 2009] 
Appendix K2 

40 CFR Part 60 Subpart Ec
K-16 

APPENDIX K2--40 CFR PART 60 SUBPART Ec 

Note: CFR text for 40 CFR Part 60 subpart Ec accessed Jun. 11, 2010 at e-CFR web site: 

http://ecfr.gpoaccess.gov. 

Subpart Ec—Standards of Performance for Hospital/Medical/Infectious Waste Incinerators for 

Which Construction is Commenced After June 20, 1996 

Source: 62 FR 48382, Sept. 15, 1997, unless otherwise noted. 

§ 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. 

 (b) A combustor is not subject to this subpart during periods when only pathological 

waste, low-level radioactive waste, and/or chemotherapeutic waste (all defined in §60.51c) is 

burned, provided the owner or operator of the combustor: 

 (1) Notifies the Administrator of an exemption claim; and 

 (2) Keeps records on a calendar quarter basis of the periods of time when only 

pathological waste, low-level radioactive waste and/or chemotherapeutic waste is burned. 

 (c) Any co-fired combustor (defined in §60.51c) is not subject to this subpart if the owner 

or operator of the co-fired combustor: 

 (1) Notifies the Administrator of an exemption claim; 

 (2) Provides an estimate of the relative amounts of hospital waste, medical/infectious 

waste, and other fuels and wastes to be combusted; and 

 (3) Keeps records on a calendar quarter basis of the weight of hospital waste and 

medical/infectious waste combusted, and the weight of all other fuels and wastes combusted at 

the co-fired combustor. 

 (d) Any combustor required to have a permit under section 3005 of the Solid Waste 

Disposal Act is not subject to this subpart. 

 (e) Any combustor which meets the applicability requirements under subpart Cb, Ea, or 

Eb of this part (standards or guidelines for certain municipal waste combustors) is not subject to 

this subpart. 

 (f) Any pyrolysis unit (defined in §60.51c) is not subject to this subpart. 

 (g) Cement kilns firing hospital waste and/or medical/infectious waste are not subject to 

this subpart. 

 (h) Physical or operational changes made to an existing HMIWI solely for the purpose of 

complying with emission guidelines under subpart Ce are not considered a modification and do 

not result in an existing HMIWI becoming subject to this subpart. 

 (i) In delegating implementation and enforcement authority to a State under section 

111(c) of the Clean Air Act, the following authorities shall be retained by the Administrator and 

not transferred to a State: 
K-17 

 (1) The requirements of § 60.56c(i) establishing operating parameters when using 

controls other than those listed in § 60.56c(d). 

 (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). 

(j) Affected facilities subject to this subpart are not subject to the requirements of 40 CFR 

part 64. 

 (k) The requirements of this subpart shall become effective March 16, 1998 

 (l) Beginning September 15, 2000, or on the effective date of an EPA-approved operating 

permit program under Clean Air Act title V and the implementing regulations under 40 CFR part 

70 in the State in which the unit is located, whichever date is later, affected facilities subject to 

this subpart shall operate pursuant to a permit issued under the EPA approved State operating 

permit program. 

 (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. 

[62 FR 48382, Sept. 15, 1997, as amended at 74 FR 51408, Oct. 6, 2009] 

§ 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. 

Batch HMIWI means an HMIWI that is designed such that neither waste charging nor 

ash removal can occur during combustion. 

Biologicals means preparations made from living organisms and their products, including 

vaccines, cultures, etc., intended for use in diagnosing, immunizing, or treating humans or 

animals or in research pertaining thereto. 
K-18 

Blood products means any product derived from human blood, including but not limited 

to blood plasma, platelets, red or white blood corpuscles, and other derived licensed products, 

such as interferon, etc. 

Body fluids means liquid emanating or derived from humans and limited to blood; 

dialysate; amniotic, cerebrospinal, synovial, pleural, peritoneal and pericardial fluids; and semen 

and vaginal secretions. 

Bypass stack means a device used for discharging combustion gases to avoid severe 

damage to the air pollution control device or other equipment. 

Chemotherapeutic waste means waste material resulting from the production or use of 

antineoplastic agents used for the purpose of stopping or reversing the growth of malignant cells. 

Co-fired combustor means a unit combusting hospital waste and/or medical/infectious 

waste with other fuels or wastes (e.g., coal, municipal solid waste) and subject to an enforceable 

requirement limiting the unit to combusting a fuel feed stream, 10 percent or less of the weight 

of which is comprised, in aggregate, of hospital waste and medical/infectious waste as measured 

on a calendar quarter basis. For purposes of this definition, pathological waste, chemotherapeutic 

waste, and low-level radioactive waste are considered “other” wastes when calculating the 

percentage of hospital waste and medical/infectious waste combusted. 

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. 

Continuous emission monitoring system or CEMS means a monitoring system for 

continuously measuring and recording the emissions of a pollutant from an affected facility. 

Continuous HMIWI means an HMIWI that is designed to allow waste charging and ash 

removal during combustion. 

Dioxins/furans means the combined emissions of tetra-through octa-chlorinated dibenzopara-dioxins and dibenzofurans, as measured by EPA Reference Method 23. 

Dry scrubber means an add-on air pollution control system that injects dry alkaline 

sorbent (dry injection) or sprays an alkaline sorbent (spray dryer) to react with and neutralize 

acid gases in the HMIWI exhaust stream forming a dry powder material. 

Fabric filter or baghouse means an add-on air pollution control system that removes 

particulate matter (PM) and nonvaporous metals emissions by passing flue gas through filter 

bags. 

Facilities manager means the individual in charge of purchasing, maintaining, and 

operating the HMIWI or the owner's or operator's representative responsible for the management 

of the HMIWI. Alternative titles may include director of facilities or vice president of support 

services. 

High-air phase means the stage of the batch operating cycle when the primary chamber 

reaches and maintains maximum operating temperatures. 

Hospital means any facility which has an organized medical staff, maintains at least six 

inpatient beds, and where the primary function of the institution is to provide diagnostic and 

therapeutic patient services and continuous nursing care primarily to human inpatients who are 

not related and who stay on average in excess of 24 hours per admission. This definition does not 

include facilities maintained for the sole purpose of providing nursing or convalescent care to 

human patients who generally are not acutely ill but who require continuing medical supervision. 

Hospital/medical/infectious waste incinerator or HMIWI or HMIWI unit means any 

device that combusts any amount of hospital waste and/or medical/infectious waste. 
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Hospital/medical/infectious waste incinerator operator or HMIWI operator means any 

person who operates, controls or supervises the day-to-day operation of an HMIWI. 

Hospital waste means discards generated at a hospital, except unused items returned to 

the manufacturer. The definition of hospital waste does not include human corpses, remains, and 

anatomical parts that are intended for interment or cremation. 

Infectious agent means any organism (such as a virus or bacteria) that is capable of being 

communicated by invasion and multiplication in body tissues and capable of causing disease or 

adverse health impacts in humans. 

Intermittent HMIWI means an HMIWI that is designed to allow waste charging, but not 

ash removal, during combustion. 

Large HMIWI means: 

 (1) Except as provided in (2); 

 (i) An HMIWI whose maximum design waste burning capacity is more than 500 pounds 

per hour; or 

 (ii) A continuous or intermittent HMIWI whose maximum charge rate is more than 500 

pounds per hour; or 

 (iii) A batch HMIWI whose maximum charge rate is more than 4,000 pounds per day. 

 (2) The following are not large HMIWI: 

 (i) A continuous or intermittent HMIWI whose maximum charge rate is less than or equal 

to 500 pounds per hour; or 

 (ii) A batch HMIWI whose maximum charge rate is less than or equal to 4,000 pounds 

per day. 

Low-level radioactive waste means waste material which contains radioactive nuclides 

emitting primarily beta or gamma radiation, or both, in concentrations or quantities that exceed 

applicable federal or State standards for unrestricted release. Low-level radioactive waste is not 

high-level radioactive waste, spent nuclear fuel, or by-product material as defined by the Atomic 

Energy Act of 1954 (42 U.S.C. 2014(e)(2)). 

Malfunction means any sudden, infrequent, and not reasonably preventable failure of air 

pollution control equipment, process equipment, or a process to operate in a normal or usual 

manner. Failures that are caused, in part, by poor maintenance or careless operation are not 

malfunctions. During periods of malfunction the operator shall operate within established 

parameters as much as possible, and monitoring of all applicable operating parameters shall 

continue until all waste has been combusted or until the malfunction ceases, whichever comes 

first. 

Maximum charge rate means: 

 (1) For continuous and intermittent HMIWI, 110 percent of the lowest 3-hour average 

charge rate measured during the most recent performance test demonstrating compliance with all 

applicable emission limits. 

 (2) For batch HMIWI, 110 percent of the lowest daily charge rate measured during the 

most recent performance test demonstrating compliance with all applicable emission limits. 

Maximum design waste burning capacity means: 

 (1) For intermittent and continuous HMIWI, 

C=PV× 15,000/8,500 

Where: 

C=HMIWI capacity, lb/hr 
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PV=primary chamber volume, ft3 

15,000=primary chamber heat release rate factor, Btu/ft3 /hr 

8,500=standard waste heating value, Btu/lb; 

 (2) For batch HMIWI, 

C=PV× 4.5/8 

Where: 

C=HMIWI capacity, lb/hr 

PV=primary chamber volume, ft3 

4.5=waste density, lb/ft3 

8=typical hours of operation of a batch HMIWI, hours. 

Maximum fabric filter inlet temperature means 110 percent of the lowest 3-hour average 

temperature at the inlet to the fabric filter (taken, at a minimum, once every minute) measured 

during the most recent performance test demonstrating compliance with the dioxin/furan 

emission limit. 

Maximum flue gas temperature means 110 percent of the lowest 3-hour average 

temperature at the outlet from the wet scrubber (taken, at a minimum, once every minute) 

measured during the most recent performance test demonstrating compliance with the mercury 

(Hg) emission limit. 

Medical/infectious waste means any waste generated in the diagnosis, treatment, or 

immunization of human beings or animals, in research pertaining thereto, or in the production or 

testing of biologicals that is listed in paragraphs (1) through (7) of this definition. The definition 

of medical/infectious waste does not include hazardous waste identified or listed under the 

regulations in part 261 of this chapter; household waste, as defined in §261.4(b)(1) of this 

chapter; ash from incineration of medical/infectious waste, once the incineration process has 

been completed; human corpses, remains, and anatomical parts that are intended for interment or 

cremation; and domestic sewage materials identified in §261.4(a)(1) of this chapter. 

 (1) Cultures and stocks of infectious agents and associated biologicals, including: 

cultures from medical and pathological laboratories; cultures and stocks of infectious agents 

from research and industrial laboratories; wastes from the production of biologicals; discarded 

live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix 

cultures. 

 (2) Human pathological waste, including tissues, organs, and body parts and body fluids 

that are removed during surgery or autopsy, or other medical procedures, and specimens of body 

fluids and their containers. 

 (3) Human blood and blood products including: 

 (i) Liquid waste human blood; 

 (ii) Products of blood; 

 (iii) Items saturated and/or dripping with human blood; or 

 (iv) Items that were saturated and/or dripping with human blood that are now caked with 

dried human blood; including serum, plasma, and other blood components, and their containers, 

which were used or intended for use in either patient care, testing and laboratory analysis or the 

development of pharmaceuticals. Intravenous bags are also included in this category. 
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 (4) Sharps that have been used in animal or human patient care or treatment or in 

medical, research, or industrial laboratories, including hypodermic needles, syringes (with or 

without the attached needle), pasteur pipettes, scalpel blades, blood vials, needles with attached 

tubing, and culture dishes (regardless of presence of infectious agents). Also included are other 

types of broken or unbroken glassware that were in contact with infectious agents, such as used 

slides and cover slips. 

 (5) Animal waste including contaminated animal carcasses, body parts, and bedding of 

animals that were known to have been exposed to infectious agents during research (including 

research in veterinary hospitals), production of biologicals or testing of pharmaceuticals. 

 (6) Isolation wastes including biological waste and discarded materials contaminated 

with blood, excretions, exudates, or secretions from humans who are isolated to protect others 

from certain highly communicable diseases, or isolated animals known to be infected with highly 

communicable diseases. 

 (7) Unused sharps including the following unused, discarded sharps: hypodermic needles, 

suture needles, syringes, and scalpel blades. 

Medium HMIWI means: 

 (1) Except as provided in paragraph (2); 

 (i) An HMIWI whose maximum design waste burning capacity is more than 200 pounds 

per hour but less than or equal to 500 pounds per hour; or 

 (ii) A continuous or intermittent HMIWI whose maximum charge rate is more than 200 

pounds per hour but less than or equal to 500 pounds per hour; or 

 (iii) A batch HMIWI whose maximum charge rate is more than 1,600 pounds per day but 

less than or equal to 4,000 pounds per day. 

 (2) The following are not medium HMIWI: 

 (i) A continuous or intermittent HMIWI whose maximum charge rate is less than or equal 

to 200 pounds per hour or more than 500 pounds per hour; or 

 (ii) A batch HMIWI whose maximum charge rate is more than 4,000 pounds per day or 

less than or equal to 1,600 pounds per day. 

Minimum dioxin/furan sorbent flow rate means 90 percent of the highest 3-hour average 

dioxin/furan sorbent flow rate (taken, at a minimum, once every hour) measured during the most 

recent performance test demonstrating compliance with the dioxin/furan emission limit. 

Minimum Hg sorbent flow rate means 90 percent of the highest 3-hour average Hg 

sorbent flow rate (taken, at a minimum, once every hour) measured during the most recent 

performance test demonstrating compliance with the Hg emission limit. 

Minimum hydrogen chloride (HCl) sorbent flow rate means 90 percent of the highest 3-

hour average HCl sorbent flow rate (taken, at a minimum, once every hour) measured during the 

most recent performance test demonstrating compliance with the HCl emission limit. 

Minimum horsepower or amperage means 90 percent of the highest 3-hour average 

horsepower or amperage to the wet scrubber (taken, at a minimum, once every minute) measured 

during the most recent performance test demonstrating compliance with the applicable emission 

limits. 

Minimum pressure drop across the wet scrubber means 90 percent of the highest 3-hour 

average pressure drop across the wet scrubber PM control device (taken, at a minimum, once 

every minute) measured during the most recent performance test demonstrating compliance with 

the PM emission limit. 

Minimum 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 
K-22 

every minute) measured during the most recent performance test demonstrating compliance with 

the NOX emissions limit. 

Minimum scrubber liquor flow rate means 90 percent of the highest 3-hour average 

liquor flow rate at the inlet to the wet scrubber (taken, at a minimum, once every minute) 

measured during the most recent performance test demonstrating compliance with all applicable 

emission limits. 

Minimum scrubber liquor pH means 90 percent of the highest 3-hour average liquor pH 

at the inlet to the wet scrubber (taken, at a minimum, once every minute) measured during the 

most recent performance test demonstrating compliance with the HCl emission limit. 

Minimum secondary chamber temperature means 90 percent of the highest 3-hour 

average secondary chamber temperature (taken, at a minimum, once every minute) measured 

during the most recent performance test demonstrating compliance with the PM, CO, 

dioxin/furan, and NOX emissions limits. 

Modification or Modified HMIWI means any change to an HMIWI unit after the 

effective date of these standards such that: 

 (1) The cumulative costs of the modifications, over the life of the unit, exceed 50 per 

centum of the original cost of the construction and installation of the unit (not including the cost 

of any land purchased in connection with such construction or installation) updated to current 

costs, or 

 (2) The change involves a physical change in or change in the method of operation of the 

unit which increases the amount of any air pollutant emitted by the unit for which standards have 

been established under section 129 or section 111. 

Operating day means a 24-hour period between 12:00 midnight and the following 

midnight during which any amount of hospital waste or medical/infectious waste is combusted at 

any time in the HMIWI. 

Operation means the period during which waste is combusted in the incinerator excluding 

periods of startup or shutdown. 

Particulate matter or PM means the total particulate matter emitted from an HMIWI as 

measured by EPA Reference Method 5 or EPA Reference Method 29. 

Pathological waste means waste material consisting of only human or animal remains, 

anatomical parts, and/or tissue, the bags/containers used to collect and transport the waste 

material, and animal bedding (if applicable). 

Primary chamber means the chamber in an HMIWI that receives waste material, in which 

the waste is ignited, and from which ash is removed. 

Pyrolysis means the endothermic gasification of hospital waste and/or medical/infectious 

waste using external energy. 

Secondary chamber means a component of the HMIWI that receives combustion gases 

from the primary chamber and in which the combustion process is completed. 

Shutdown means the period of time after all waste has been combusted in the primary 

chamber. For continuous HMIWI, shutdown shall commence no less than 2 hours after the last 

charge to the incinerator. For intermittent HMIWI, shutdown shall commence no less than 4 

hours after the last charge to the incinerator. For batch HMIWI, shutdown shall commence no 

less than 5 hours after the high-air phase of combustion has been completed. 

Small HMIWI means: 

 (1) Except as provided in (2); 

 (i) An HMIWI whose maximum design waste burning capacity is less than or equal to 

200 pounds per hour; or 
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 (ii) A continuous or intermittent HMIWI whose maximum charge rate is less than or 

equal to 200 pounds per hour; or 

 (iii) A batch HMIWI whose maximum charge rate is less than or equal to 1,600 pounds 

per day. 

 (2) The following are not small HMIWI: 

 (i) A continuous or intermittent HMIWI whose maximum charge rate is more than 200 

pounds per hour; 

 (ii) A batch HMIWI whose maximum charge rate is more than 1,600 pounds per day. 

Standard conditions means a temperature of 20 °C and a pressure of 101.3 kilopascals. 

Startup means the period of time between the activation of the system and the first charge 

to the unit. For batch HMIWI, startup means the period of time between activation of the system 

and ignition of the waste. 

Wet scrubber means an add-on air pollution control device that utilizes an alkaline 

scrubbing liquor to collect particulate matter (including nonvaporous metals and condensed 

organics) and/or to absorb and neutralize acid gases. 

[62 FR 48382, Sept. 15, 1997, as amended at 74 FR 51408, Oct. 6, 2009] 

§ 60.52c Emission limits. 

 (a) On and after the date on which the initial performance test is completed or is required 

to be completed under §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. 

 (d) The emission limit specified in paragraph (c) of this section does not cover visible 

emissions discharged inside buildings or enclosures of ash conveying systems; however, the 

emission limit does cover visible emissions discharged to the atmosphere from buildings or 

enclosures of ash conveying systems. 

 (e) The provisions specified in paragraph (c) of this section do not apply during 

maintenance and repair of ash conveying systems. Maintenance and/or repair shall not exceed 10 

operating days per calendar quarter unless the owner or operator obtains written approval from 
K-24 

the State agency establishing a date whereby all necessary maintenance and repairs of ash 

conveying systems shall be completed. 

[62 FR 48382, Sept. 15, 1997, as amended at 74 FR 51409, Oct. 6, 2009] 

§ 60.53c Operator training and qualification requirements. 

 (a) No owner or operator of an affected facility shall allow the affected facility to operate 

at any time unless a fully trained and qualified HMIWI operator is accessible, either at the 

facility or available within 1 hour. The trained and qualified HMIWI operator may operate the 

HMIWI directly or be the direct supervisor of one or more HMIWI operators. 

 (b) Operator training and qualification shall be obtained through a State-approved 

program or by completing the requirements included in paragraphs (c) through (g) of this 

section. 

 (c) Training shall be obtained by completing an HMIWI operator training course that 

includes, at a minimum, the following provisions: 

 (1) 24 hours of training on the following subjects: 

 (i) Environmental concerns, including pathogen destruction and types of emissions; 

 (ii) Basic combustion principles, including products of combustion; 

 (iii) Operation of the type of incinerator to be used by the operator, including proper 

startup, waste charging, and shutdown procedures; 

 (iv) Combustion controls and monitoring; 

 (v) Operation of air pollution control equipment and factors affecting performance (if 

applicable); 

 (vi) Methods to monitor pollutants (continuous emission monitoring systems and 

monitoring of HMIWI and air pollution control device operating parameters) and equipment 

calibration procedures (where applicable); 

 (vii) Inspection and maintenance of the HMIWI, air pollution control devices, and 

continuous emission monitoring systems; 

 (viii) Actions to correct malfunctions or conditions that may lead to malfunction; 

 (ix) Bottom and fly ash characteristics and handling procedures; 

 (x) Applicable Federal, State, and local regulations; 

 (xi) Work safety procedures; 

 (xii) Pre-startup inspections; and 

 (xiii) Recordkeeping requirements. 

 (2) An examination designed and administered by the instructor. 

 (3) Reference material distributed to the attendees covering the course topics. 

 (d) Qualification shall be obtained by: 

 (1) Completion of a training course that satisfies the criteria under paragraph (c) of this 

section; and 

 (2) Either 6 months experience as an HMIWI operator, 6 months experience as a direct 

supervisor of an HMIWI operator, or completion of at least two burn cycles under the 

observation of two qualified HMIWI operators. 

 (e) Qualification is valid from the date on which the examination is passed or the 

completion of the required experience, whichever is later. 

 (f) To maintain qualification, the trained and qualified HMIWI operator shall complete 

and pass an annual review or refresher course of at least 4 hours covering, at a minimum, the 

following: 

 (1) Update of regulations; 
K-25 

 (2) Incinerator operation, including startup and shutdown procedures; 

 (3) Inspection and maintenance; 

 (4) Responses to malfunctions or conditions that may lead to malfunction; and 

 (5) Discussion of operating problems encountered by attendees. 

 (g) A lapsed qualification shall be renewed by one of the following methods: 

 (1) For a lapse of less than 3 years, the HMIWI operator shall complete and pass a 

standard annual refresher course described in paragraph (f) of this section. 

 (2) For a lapse of 3 years or more, the HMIWI operator shall complete and pass a training 

course with the minimum criteria described in paragraph (c) of this section. 

 (h) The owner or operator of an affected facility shall maintain documentation at the 

facility that address the following: 

 (1) Summary of the applicable standards under this subpart; 

 (2) Description of basic combustion theory applicable to an HMIWI; 

 (3) Procedures for receiving, handling, and charging waste; 

 (4) HMIWI startup, shutdown, and malfunction procedures; 

 (5) Procedures for maintaining proper combustion air supply levels; 

 (6) Procedures for operating the HMIWI and associated air pollution control systems 

within the standards established under this subpart; 

 (7) Procedures for responding to periodic malfunction or conditions that may lead to 

malfunction; 

 (8) Procedures for monitoring HMIWI emissions; 

 (9) Reporting and recordkeeping procedures; and 

 (10) Procedures for handling ash. 

 (i) The owner or operator of an affected facility shall establish a program for reviewing 

the information listed in paragraph (h) of this section annually with each HMIWI operator 

(defined in §60.51c). 

 (1) The initial review of the information listed in paragraph (h) of this section shall be 

conducted within 6 months after the effective date of this subpart or prior to assumption of 

responsibilities affecting HMIWI operation, whichever date is later. 

 (2) Subsequent reviews of the information listed in paragraph (h) of this section shall be 

conducted annually. 

 (j) The information listed in paragraph (h) of this section shall be kept in a readily 

accessible location for all HMIWI operators. This information, along with records of training 

shall be available for inspection by the EPA or its delegated enforcement agent upon request. 

§ 60.54c Siting requirements. 

 (a) The owner or operator of an affected facility for which construction is commenced 

after September 15, 1997 shall prepare an analysis of the impacts of the affected facility. The 

analysis shall consider air pollution control alternatives that minimize, on a site-specific basis, to 

the maximum extent practicable, potential risks to public health or the environment. In 

considering such alternatives, the analysis may consider costs, energy impacts, non-air 

environmental impacts, or any other factors related to the practicability of the alternatives. 

 (b) Analyses of facility impacts prepared to comply with State, local, or other Federal 

regulatory requirements may be used to satisfy the requirements of this section, as long as they 

include the consideration of air pollution control alternatives specified in paragraph (a) of this 

section. 
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 (c) The owner or operator of the affected facility shall complete and submit the siting 

requirements of this section as required under §60.58c(a)(1)(iii). 

§ 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. 

[74 FR 51409, Oct. 6, 2009] 

§ 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. 

 (1) All performance tests shall consist of a minimum of three test runs conducted under 

representative operating conditions. 

 (2) The minimum sample time shall be 1 hour per test run unless otherwise indicated. 

 (3) EPA Reference Method 1 of appendix A of this part shall be used to select the 

sampling location and number of traverse points. 

 (4) EPA Reference Method 3, 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). 
K-27 

 (5) The pollutant concentrations shall be adjusted to 7 percent oxygen using the 

following equation: 

Cadj=Cmeas(20.9−7)/(20.9−%O2) 

where: 

Cadj=pollutant concentration adjusted to 7 percent oxygen; 

Cmeas=pollutant concentration measured on a dry basis (20.9−7)=20.9 percent oxygen—7 percent 

oxygen (defined oxygen correction basis); 

20.9=oxygen concentration in air, percent; and 

%O2=oxygen concentration measured on a dry basis, percent. 

 (6) EPA Reference Method 5 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. 

 (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: 

 (i) Measure the concentration of each dioxin/furan tetra-through octa-congener emitted 

using EPA Reference Method 23. 

 (ii) For each dioxin/furan congener measured in accordance with paragraph (b)(9)(i) of 

this section, multiply the congener concentration by its corresponding toxic equivalency factor 

specified in table 2 of this subpart. 

 (iii) Sum the products calculated in accordance with paragraph (b)(9)(ii) of this section to 

obtain the total concentration of dioxins/furans emitted in terms of toxic equivalency. 

 (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 
K-28 

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) Following the date on which the initial performance test is completed or is required to 

be completed under §60.8, whichever date comes first, the owner or operator of an affected 

facility shall: 

 (1) Determine compliance with the opacity limit by conducting an annual performance 

test (no more than 12 months following the previous performance test) using the applicable 

procedures and test methods listed in paragraph (b) of this section. 

 (2) 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. 
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 (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 site-specific 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 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 

site-specific 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: 

 (1) Establish the appropriate maximum and minimum operating parameters, indicated in 

table 3 of this subpart for each control system, as site specific operating parameters during the 

initial performance test to determine compliance with the emission limits; and 

 (2) Following the date on which the initial performance test is completed or is required to 

be completed under §60.8, whichever date comes first, ensure that the affected facility does not 

operate above any of the applicable maximum operating parameters or below any of the 

applicable minimum operating parameters listed in table 3 of this subpart and measured as 3-
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hour rolling averages (calculated each hour as the average of the previous 3 operating hours) at 

all times except during periods of startup, shutdown and malfunction. Operating parameter limits 

do not apply during performance tests. Operation above the established maximum or below the 

established minimum operating parameter(s) shall constitute a violation of established operating 

parameter(s). 

 (e) Except as provided in paragraph (i) of this section, for affected facilities equipped 

with a dry scrubber followed by a fabric filter: 

 (1) Operation of the affected facility above the maximum charge rate and below the 

minimum secondary chamber temperature (each measured on a 3-hour rolling average) 

simultaneously shall constitute a violation of the CO emission limit. 

 (2) Operation of the affected facility above the maximum fabric filter inlet temperature, 

above the maximum charge rate, and below the minimum dioxin/furan sorbent flow rate (each 

measured on a 3-hour rolling average) simultaneously shall constitute a violation of the 

dioxin/furan emission limit. 

 (3) Operation of the affected facility above the maximum charge rate and below the 

minimum HCl sorbent flow rate (each measured on a 3-hour rolling average) simultaneously 

shall constitute a violation of the HCl emission limit. 

 (4) Operation of the affected facility above the maximum charge rate and below the 

minimum Hg sorbent flow rate (each measured on a 3-hour rolling average) simultaneously shall 

constitute a violation of the Hg emission limit. 

 (5) Use of the bypass stack 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: 
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 (1) Operation of the affected facility above the maximum charge rate and below the 

minimum pressure drop across the wet scrubber or below the minimum horsepower or amperage 

to the system (each measured on a 3-hour rolling average) simultaneously shall constitute a 

violation of the PM emission limit. 

 (2) Operation of the affected facility above the maximum charge rate and below the 

minimum secondary chamber temperature (each measured on a 3-hour rolling average) 

simultaneously shall constitute a violation of the CO emission limit. 

 (3) Operation of the affected facility above the maximum charge rate, below the 

minimum secondary chamber temperature, and below the minimum scrubber liquor flow rate 

(each measured on a 3-hour rolling average) simultaneously shall constitute a violation of the 

dioxin/furan emission limit. 

 (4) Operation of the affected facility above the maximum charge rate and below the 

minimum scrubber liquor pH (each measured on a 3-hour rolling average) simultaneously shall 

constitute a violation of the HCl emission limit. 

 (5) Operation of the affected facility above the maximum flue gas temperature and above 

the maximum charge rate (each measured on a 3-hour rolling average) simultaneously shall 

constitute a violation of the Hg emission limit. 

 (6) Use of the bypass stack 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: 

 (1) Operation of the affected facility above the maximum charge rate and below the 

minimum secondary chamber temperature (each measured on a 3-hour rolling average) 

simultaneously shall constitute a violation of the CO emission limit. 

 (2) Operation of the affected facility above the maximum fabric filter inlet temperature, 

above the maximum charge rate, and below the minimum dioxin/furan sorbent flow rate (each 

measured on a 3-hour rolling average) simultaneously shall constitute a violation of the 

dioxin/furan emission limit. 

 (3) Operation of the affected facility above the maximum charge rate and below the 

minimum scrubber liquor pH (each measured on a 3-hour rolling average) simultaneously shall 

constitute a violation of the HCl emission limit. 

 (4) Operation of the affected facility above the maximum charge rate and below the 

minimum Hg sorbent flow rate (each measured on a 3-hour rolling average) simultaneously shall 

constitute a violation of the Hg emission limit. 
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 (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 §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 
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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 site-specific 

operating parameters to be established during the initial performance test and continuously 

monitored thereafter. The owner or operator shall not conduct the initial performance test until 

after the petition has been approved by the Administrator. 

 (k) The owner or operator of an affected facility may conduct a repeat performance test at 

any time to establish new values for the operating parameters. The Administrator may request a 

repeat performance test at any time. 

[62 FR 48382, Sept. 15, 1997, as amended at 65 FR 61753, Oct. 17, 2000; 74 FR 51409, Oct. 6, 

2009] 

§ 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. 

 (c) The owner or operator of an affected facility shall install, calibrate (to manufacturers' 

specifications), maintain, and operate a device or method for measuring the use of the bypass 

stack including date, time, and duration. 

 (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; 
K-34 

 (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 

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 
K-35 

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. 

[62 FR 48382, Sept. 15, 1997, as amended at 74 FR 51412, Oct. 6, 2009] 

§ 60.58c Reporting and recordkeeping requirements. 

 (a) The owner or operator of an affected facility shall submit notifications, as provided by 

§60.7. In addition, the owner or operator shall submit the following information: 

 (1) Prior to commencement of construction; 

 (i) A statement of intent to construct; 

 (ii) The anticipated date of commencement of construction; and 

 (iii) All documentation produced as a result of the siting requirements of §60.54c. 

 (2) Prior to initial startup; 

 (i) The type(s) of waste to be combusted; 

 (ii) The maximum design waste burning capacity; 

 (iii) The anticipated maximum charge rate; and 

 (iv) If applicable, the petition for site-specific operating parameters under §60.56c(j). 

 (b) The owner or operator of an affected facility shall maintain the following information 

(as applicable) for a period of at least 5 years: 

 (1) Calendar date of each record; 

 (2) Records of the following data: 

 (i) Concentrations of any pollutant listed in §60.52c or measurements of opacity as 

determined by the continuous emission monitoring system (if applicable); 

 (ii) Results of fugitive emissions (by EPA Reference Method 22) tests, if applicable; 

 (iii) HMIWI charge dates, times, and weights and hourly charge rates; 

 (iv) Fabric filter inlet temperatures during each minute of operation, as applicable; 

 (v) Amount and type of dioxin/furan sorbent used during each hour of operation, as 

applicable; 

 (vi) Amount and type of Hg sorbent used during each hour of operation, as applicable; 

 (vii) Amount and type of HCl sorbent used during each hour of operation, as applicable; 

 (viii) 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; 

 (ix) Secondary chamber temperatures recorded during each minute of operation; 

 (x) Liquor flow rate to the wet scrubber inlet during each minute of operation, as 

applicable; 

 (xi) Horsepower or amperage to the wet scrubber during each minute of operation, as 

applicable; 

 (xii) Pressure drop across the wet scrubber system during each minute of operation, as 

applicable, 
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 (xiii) Temperature at the outlet from the wet scrubber during each minute of operation, as 

applicable; 

 (xiv) pH at the inlet to the wet scrubber during each minute of operation, as applicable, 

 (xv) Records indicating use of the bypass stack, including dates, times, and durations, 

and 

 (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. 

 (3) Identification of calendar days for which data on emission rates or operating 

parameters specified under paragraph (b)(2) of this section have not been obtained, with an 

identification of the emission rates or operating parameters not measured, reasons for not 

obtaining the data, and a description of corrective actions taken. 

 (4) Identification of calendar days, times and durations of malfunctions, a description of 

the malfunction and the corrective action taken. 

 (5) Identification of calendar days for which data on emission rates or operating 

parameters specified under paragraph (b)(2) of this section exceeded the applicable limits, with a 

description of the exceedances, reasons for such exceedances, and a description of corrective 

actions taken. 

 (6) The results of the initial, annual, and any subsequent performance tests conducted to 

determine compliance with the emissions limits and/or to establish or re-establish operating 

parameters, as applicable, and a description, including sample calculations, of how the operating 

parameters were established or re-established, if applicable. 

 (7) All documentation produced as a result of the siting requirements of §60.54c; 

 (8) Records showing the names of HMIWI operators who have completed review of the 

information in §60.53c(h) as required by §60.53c(i), including the date of the initial review and 

all subsequent annual reviews; 

 (9) Records showing the names of the HMIWI operators who have completed the 

operator training requirements, including documentation of training and the dates of the training; 

 (10) Records showing the names of the HMIWI operators who have met the criteria for 

qualification under §60.53c and the dates of their qualification; and 

 (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. 
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 (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. 

 (3) The waste management plan as specified in §60.55c. 

 (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 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. 

 (4) Any information recorded under paragraphs (b)(3) through (b)(5) of this section for 

the calendar year being reported. 

 (5) Any information recorded under paragraphs (b)(3) through (b)(5) of this section for 

the calendar year preceding the year being reported, in order to provide the Administrator with a 

summary of the performance of the affected facility over a 2-year period. 

 (6) If a performance test was conducted during the reporting period, the results of that 

test. 

 (7) If no exceedances or malfunctions were reported under paragraphs (b)(3) through 

(b)(5) of this section for the calendar year being reported, a statement that no exceedances 

occurred during the reporting period. 

 (8) Any use of the bypass stack, the duration, reason for malfunction, and corrective 

action taken. 

 (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. 

 (e) The owner or operator of an affected facility shall submit semiannual reports 

containing any information recorded under paragraphs (b)(3) through (b)(5) of this section no 

later than 60 days following the reporting period. The first semiannual reporting period ends 6 

months following the submission of information in paragraph (c) of this section. Subsequent 
K-38 

reports shall be submitted no later than 6 calendar months following the previous report. All 

reports shall be signed by the facilities manager. 

 (f) All records specified under paragraph (b) of this section shall be maintained onsite in 

either paper copy or computer-readable format, unless an alternative format is approved by the 

Administrator. 

 (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. 

[62 FR 48382, Sept. 15, 1997, as amended at 74 FR 51413, Oct. 6, 2009] 

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 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

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. 
K-39 

Pollutant 

Units (7 percent oxygen, dry 

basis) 

Emissions limits 

Averaging 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

Small Medium Large 

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. 

1

Except 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). 

[74 FR 51414, Oct. 6, 2009] 

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 

compliance2

HMIWI size 

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 

EPA Reference 

Method 26 or 26A of 

appendix A–8 of part 
K-40 

Pollutant 

Units (7 percent oxygen, 

dry basis) 

Emissions limits 

Averaging 

time1

Method for 

demonstrating 

compliance2

HMIWI size 

Small Medium Large 

sample time 

per run) 

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. 

1

Except 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). 

[74 FR 51414, Oct. 6, 2009] 

Table 2 of Subpart Ec to Part 60—Toxic Equivalency Factors 

Dioxin/furan congener Toxic equivalency factor 

2,3,7,8-tetrachlorinated dibenzo-p-dioxin 1

1,2,3,7,8-pentachlorinated dibenzo-p-dioxin 0.5

1,2,3,4,7,8-hexachlorinated dibenzo-p-dioxin 0.1

1,2,3,7,8,9-hexachlorinated dibenzo-p-dioxin 0.1

1,2,3,6,7,8-hexachlorinated dibenzo-p-dioxin 0.1

1,2,3,4,6,7,8-heptachlorinated dibenzo-p-dioxin 0.01

octachlorinated dibenzo-p-dioxin 0.001

2,3,7,8-tetrachlorinated dibenzofuran 0.1

2,3,4,7,8-pentachlorinated dibenzofuran 0.5

1,2,3,7,8-pentachlorinated dibenzofuran 0.05

1,2,3,4,7,8-hexachlorinated dibenzofuran 0.1
K-41 

1,2,3,6,7,8-hexachlorinated dibenzofuran 0.1

1,2,3,7,8,9-hexachlorinated dibenzofuran 0.1

2,3,4,6,7,8-hexachlorinated dibenzofuran 0.1

1,2,3,4,6,7,8-heptachlorinated dibenzofuran 0.01

1,2,3,4,7,8,9-heptachlorinated dibenzofuran 0.01

Octachlorinated dibenzofuran 0.001

Table 3 to Subpart Ec of Part 60—Operating Parameters To Be Monitored and Minimum 

Measurement and Recording Frequencies 

Operating parameters to be 

monitored 

Minimum frequency Control system 

Data 

measurement

Data 

recording

Dry scrubber 

followed by 

fabric filter 

Wet 

scrubber 

Dry scrubber 

followed by fabric 

filter and wet 

scrubber 

Maximum operating parameters: 

Maximum charge rate Continuous 1×hour 3 3 3

Maximum fabric filter inlet 

temperature Continuous 1×minute 3 3

Maximum flue gas temperature Continuous 1×minute 3 3

Minimum operating parameters: 

Minimum secondary chamber 

temperature Continuous 1×minute 3 3 3

Minimum dioxin/furan sorbent 

flow rate Hourly 1×hour 3 3

Minimum HCI sorbent flow rate Hourly 1×hour 3 3

Minimum mercury (Hg) sorbent 

flow rate Hourly 1×hour 3 3

Minimum pressure drop across 

the wet scrubber or minimum 

horsepower or amperage to wet 

scrubber 

Continuous 1×minute 3 3

Minimum scrubber liquor flow 

rate Continuous 1×minute 3 3

Minimum scrubber liquor pH Continuous 1×minute 3 3
Appendix L 

Federal Register Notice for Amended Emission Guidelines and NSPS 

(40 CFR Part 60 Subparts Ce and Ec)
APPENDIX L-- FEDERAL REGISTER NOTICE FOR AMENDED EMISSION GUIDELINES 

AND NSPS (40 CFR PART 60 SUBPARTS Ce AND Ec) 

L-2 
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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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51369 

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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51370 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 

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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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51371 

III. Summary of the Final Rule and 

Changes Since Proposal 

A. Remand Response 

Today’s final response to the remand 

revises the December 2008 proposed 

emissions limits for both the NSPS and 

EG. The emissions limits are being 

revised in response to a public comment 

on the December 2008 re-proposal, 

which requested that EPA adjust the 

statistical approach used to account for 

variability in the data and consider the 

distribution of the emissions data in 

determining the MACT floor emissions 

limits. The revised statistical approach 

results in generally higher limits 

compared to the December 2008 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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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51405 

§ 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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51406 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 

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

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

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 


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Appendix M 

2010 HMIWI Inventory
APPENDIX M—2010 HMIWI INVENTORY 

No. Facility name 

Unit 

no. Street address City State Zip County 

EP

Reg

1 Bristol-Myers Squibb Co. 5 Research Parkway, 

P.O. Box 5100 

Wallingford CT 06492 New Haven 1 

2 Merck & Company, Inc. 126 E. Lincoln Avenue Rahway NJ 07065 Union 2 3 Curtis Bay Energy Unit 1 3200 Hawkins Point 

Road 

Baltimore MD 21226 Baltimore 

City 

3 

4 Curtis Bay Energy Unit 2 3200 Hawkins Point 

Road 

Baltimore MD 21226 Baltimore 

City 

3 

5 Franklin Square Hospital 

Center 

9000 Franklin Square Drive 

Baltimore MD 21237 Baltimore 3 

6 University of Maryland at 

Baltimore, Environmental Health and Safety Facility 

714 W. Lombard Street Baltimore MD 21201 Baltimore 

City 

3 

7 Fort Detrick Unit 5 Incinerator Complex, 

Building 393 

Fort Detrick MD 21702 Frederick 3 

8 Fort Detrick Unit 6 Incinerator Complex, 

Building 393 

Fort Detrick MD 21702 Frederick 3 

9 Washington County 

Hospital 

251 E. Antietam Street Hagerstown MD 21740 Washington 3 

10 Holy Spirit Hospital 503 N. 21st Street Camp Hill PA 17011 Cumberland 3 11 Hamot Medical Center 201 State Street Erie PA 16550 Erie 3 12 Riddle Memorial Hospital 1068 W. Baltimore Pike Media PA 19063 Delaware 3 13 Pennsylvania State 

University, Animal Diagnostic Lab Incinerator 

159A Physical Plant Building, Orchard Road 

State College PA 16802 Centre 3 

14 Merck & Company, Inc. Unit 2 770 Sumneytown Pike, 

P.O. Box 4 

West Point PA 19486 Montgomery 3 

15 Merck & Company, Inc. Unit 5 770 Sumneytown Pike, 

P.O. Box 4 

West Point PA 19486 Montgomery 3 

16 Charleston Area Medical 

Center, General Hospital 

501 Morris Street Charleston WV 25301 Kanawha 3 

M-2 
No. Facility name 

Unit 

no. Street address City State Zip County 

EPA 

Regi

17 Thomas Memorial 

Hospital 

4605 MacCorkle Avenue S.W. 

South Charleston 

WV 25309 Kanawha 3 

18 Stericycle, Inc. 254 W. Keene Road Apopka FL 32703 Orange 4 19 Boca Raton Community 

Hospital 

800 Meadows Road Boca Raton FL 33486 Palm Beach 4 

20 Bethesda Memorial 

Hospital 

2815 S. Seacrest Boulevard 

Boynton Beach 

FL 33435 Palm Beach 4 

21 Holy Cross Hospital 4725 N. Federal 

Highway 

Fort Lauderdale 

FL 33308 Broward 4 

22 Malcom Randall Veterans 

Affairs Medical Center 

1601 S.W. Archer Road Gainesville FL 32608 Alachua 4 

23 Memorial Regional 

Hospital 

3501 Johnson Street Hollywood FL 33021 Broward 4 

24 Lakeland Regional 

Medical Center 

1324 Lakeland Hills Boulevard 

Lakeland FL 33805 Polk 4 

25 Department of Veterans 

Affairs Medical Center 

1201 N.W. 16th Street Miami FL 33125 Miami-Dade 4 

26 Bayfront Medical Center 701 6th Street S. St. Petersburg FL 33701 Pinellas 4 27 St. Joseph's Hospital 3001 W. Martin Luther 

King Jr. Boulevard 

Tampa FL 33607 Hillsborough 4 

28 Centers for Disease 

Control and Prevention--Clifton, Building 18 

1600 Clifton Road, N.E. 

Atlanta GA 30333 DeKalb 4 

29 East Carolina University, 

Health Sciences Campus, HSC Utility Plant 

600 Moye Boulevard Greenville NC 27834 Pitt 4 

30 Stericycle, Inc. Unit 1 1168 Porter Avenue Haw River NC 27258 Alamance 4 31 Stericycle, Inc. Unit 2 1168 Porter Avenue Haw River NC 27258 Alamance 4 32 BMWNC, Inc. Unit 1 3250 Campus Ridge 

Road 

Matthews NC 28105 Mecklenburg 4 

33 St. Jude Children's 

Research Hospital 

262 Danny Thomas Place 

Memphis TN 38105 Shelby 4 

M-3 
No. Facility name 

Unit 

no. Street address City State Zip County 

EP

Regi

34 Stericycle, Inc. Unit 1 Rural Route 4, P.O. Box 

243L 

Clinton IL 61727 DeWitt 5 

35 Stericycle, Inc. Unit 2 Rural Route 4, P.O. Box 

243L 

Clinton IL 61727 DeWitt 5 

36 Loyola University Medical 

Center 

2160 S. First Avenue Maywood IL 60153 Cook 5 

37 Parkview Hospital 2200 Randallia Drive Fort Wayne IN 46805 Allen 5 38 South Bend Medical 

Foundation 

530 N. Lafayette Boulevard 

South Bend IN 46601 St. Joseph 5 

39 Good Samaritan Hospital 520 S. Seventh Street Vincennes IN 47591 Knox 5 40 Mayo Clinic, Waste 

Management Facility 

7123 L.C. Industrial Park, Rochester Municipal Airport 

Rochester MN 55905 Olmsted 5 

41 Fairfield Medical Center 401 N. Ewing Street Lancaster OH 43130 Fairfield 5 42 MedCentral Health System, 

Mansfield Hospital 

335 Glessner Avenue Mansfield OH 44903 Richland 5 

43 Medina General Hospital 1000 E. Washington 

Street 

Medina OH 44256 Medina 5 

44 Stericycle, Inc. 1901 Pine Avenue S.E. Warren OH 44483 Trumbull 5 45 Waste Management 

Resource Recovery & Recycling Center 

Unit 1 7505 State Highway 65 Anahuac TX 77514 Chambers 6 

46 Waste Management 

Resource Recovery & Recycling Center 

Unit 2 7505 State Highway 65 Anahuac TX 77514 Chambers 6 

47 University of Texas 

Medical Branch 

301 University Boulevard, Mail Route 1108 

Galveston TX 77555 Galveston 6 

48 Stericycle, Inc. 3140 N. 7th Street Kansas City KS 66115 Wyandotte 7 49 Rocky Mountain 

Laboratories 

903 S. 4th Street, Building 23 

Hamilton MT 59840 Ravalli 8 

50 Healthcare Environmental 

Services Inc. 

1420 40th Street N. Fargo ND 58102 Cass 8 

51 Stericycle, Inc. 90 N. 1100 W. North Salt Lake UT 84054 Davis 8 

M-4 
No. Facility name 

Unit 

no. Street address City State Zip County 

EP

Regi

52 Wyoming Medical Center 1233 E. Second Street Casper WY 82601 Natrona 8 53 Kona Community Hospital 79-1019 Haukapila Street Kealakekua HI 96750 Hawaii 9 54 Yukon-Kuskokwim Delta 

Regional Hospital 

829 Chief Eddie Hoffman Highway, P.O. Box 528 

Bethel AK 99559 Bethel Census 

Area 

10 

M-5 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

1 Bristol-Myers Squibb 

Co. 

Pharmaceutical Secondary chamber 

(1800°F) and baghouse 

FF Federal Plan 9/15/2002 

2 Merck & Company, Inc. Pharmaceutical Secondary chamber 

(1500°F, 1 sec), partial quench, dry acid gas scrubber with dry lime injection, and baghouse 

DIFF Federal Plan 8/15/2001 

3 Curtis Bay Energy Unit 1 Commercial Secondary chamber, dry 

scrubber, and baghouse with activated carbon injection 

DIFF State Plan 3/15/2002 

4 Curtis Bay Energy Unit 2 Commercial Secondary chamber, dry 

scrubber, and baghouse with activated carbon injection 

DIFF State Plan 3/15/2002 

5 Franklin Square Hospital 

Center 

Hospital Secondary chamber 

(1800°F) and venturi scrubber followed by quench chamber and mist eliminator 

WS State Plan 3/15/2002 

6 University of Maryland 

at Baltimore, Environmental Health and Safety Facility 

University Secondary chamber 

(1832°F) and venturi caustic scrubber with packed-bed scrubber 

WS State Plan 3/15/2002 

7 Fort Detrick Unit 5 Fed military Secondary chamber and 

rotary atomizing wet scrubber 

WS State Plan 3/15/2002 

8 Fort Detrick Unit 6 Fed military Secondary chamber and 

rotary atomizing wet scrubber 

WS State Plan 3/15/2002 

9 Washington County 

Hospital 

Hospital Secondary chamber and 

venturi caustic scrubber 

WS State Plan 3/15/2002 

M-6 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

10 Holy Spirit Hospital Hospital Secondary chamber 

(1800°F) and venturi scrubber with prequench and NaOH injection 

WS State Plan 9/15/2002 

11 Hamot Medical Center Hospital Secondary chamber 

(2000°F, 2 sec), lime injection system, powdered activated carbon injection system, baghouse, and vertical upflow two-stage multimicroventuri scrubber system 

DIFF/

WS 

State Plan 9/15/2002 

12 Riddle Memorial 

Hospital 

Hospital Secondary chamber 

(1800°F, 2 sec), caustic packed tower scrubber, and high pressure venturi, with activated carbon injection 

WS State Plan 9/15/2002 

13 Pennsylvania State 

University, Animal Diagnostic Lab Incinerator 

University Secondary chamber 

(1900°F) and rotary atomizing wet scrubber with demister 

WS State Plan 8/15/2001 

14 Merck & Company, Inc. Unit 2 University Secondary chamber 

(1900°F) and rotary atomizing wet scrubber with demister 

WS State Plan 8/15/2001 

15 Merck & Company, Inc. Unit 5 Pharmaceutical Secondary/tertiary 

chamber (2000°F, 2 sec), water quench followed by sodium bicarbonate injection system with dry reaction chamber and pulse-jet baghouse 

DIFF State Plan 9/15/2002 

M-7 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

16 Charleston Area Medical 

Center, General Hospital 

Pharmaceutical Secondary chamber 

(1800°F, 2.2 sec), water quench followed by sodium bicarbonate injection system and pulse-jet baghouse 

DIFF State Plan 9/15/2002 

17 Thomas Memorial 

Hospital 

Hospital Secondary chamber 

(1800°F, 2 sec), dry injection/baghouse scrubber system with activated carbon 

DIFF State Plan 7/28/2001 

18 Stericycle, Inc. Hospital Secondary chamber 

(1800°F) and venturi packed tower wet scrubber with caustic injection 

WS State Plan 7/28/2001 

19 Boca Raton Community 

Hospital 

Hospital Secondary chamber 

(1800°F, 1 sec) and rotary atomizing wet scrubber system with caustic soda injection 

WS State Plan 1/16/2002 

20 Bethesda Memorial 

Hospital 

Hospital Secondary chamber 

(1800°F, 2 sec) and rotary atomizing scrubber with mist eliminator 

WS State Plan 1/16/2002 

21 Holy Cross Hospital Hospital Secondary chamber 

(1800°F, 1 sec) and venturi scrubber with packed bed absorption unit using dilute NaOH 

WS State Plan 1/16/2002 

22 Malcom Randall 

Veterans Affairs Medical Center 

Fed hospital Secondary chamber 

(1800°F, 1 sec) and wet scrubber with caustic soda injection 

WS State Plan 1/16/2002 

M-8 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

23 Memorial Regional 

Hospital 

Hospital Secondary chamber 

(1800°F, 1 sec), packed column gas scrubber, and wet ESP 

WS/ 

WESP 

State Plan 1/16/2002 

24 Lakeland Regional 

Medical Center 

Hospital Secondary chamber 

(1800°F, 1 sec), lime injection system, and baghouse 

DIFF State Plan 1/16/2002 

25 Department of Veterans 

Affairs Medical Center 

Fed hospital Secondary chamber 

(1800°F, 1 sec), venturi scrubber, and packed tower absorber 

WS State Plan 

26 Bayfront Medical Center Hospital Secondary chamber 

(1800°F, 1 sec) and flux force/condensation collision scrubber system using dilute NaOH 

WS State Plan 1/16/2002 

27 St. Joseph's Hospital Hospital Secondary chamber 

(1800°F, 1 sec), lime injection, baghouse, and venturi scrubber 

DIFF/

WS 

State Plan 1/16/2002 

28 Centers for Disease 

Control and Prevention--Clifton, Building 18 

Fed research Secondary chamber 

(1800°F, 1.68 sec) and rotary atomizing wet scrubber 

WS NSPS 

29 East Carolina University, 

Health Sciences Campus, HSC Utility Plant 

University Secondary chamber 

(1985°F), rotary atomizing wet scrubber (with NaOH scrubbing medium), carbon bed adsorber, HEPA filtering system, and heat recovery system 

HEPA/

CA/ 

WS 

NSPS 

M-9 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

30 Stericycle, Inc. Unit 1 Commercial Secondary chamber 

(1800°F, 1 sec), rapid gas quench system, wet scrubber system consisting of a packed bed absorber and venturi scrubber, and demister. 

WS Federal Plan 9/15/2002 

31 Stericycle, Inc. Unit 2 Commercial Secondary chamber 

(1800°F, 1 sec), rapid gas quench system, wet scrubber system consisting of a packed bed absorber and venturi scrubber, and demister. 

WS Federal Plan 9/15/2002 

32 BMWNC, Inc. Unit 1 Commercial Secondary chamber 

(1641°F), dry scrubber with lime and activated carbon injection, and baghouse 

DIFF Federal Plan 7/1/2002 

33 St. Jude Children's 

Research Hospital 

Hospital Secondary chamber 

(1528°F) and baghouse with sodium bicarbonate and carbon injection 

DIFF Federal Plan 9/15/2002 

34 Stericycle, Inc. Unit 1 Commercial Secondary chamber 

(1800°F), venturi scrubber, and condensing absorber 

WS State Plan 9/15/2002 

35 Stericycle, Inc. Unit 2 Commercial Secondary chamber 

(1800°F), venturi scrubber, and condensing absorber 

WS State Plan 9/15/2002 

M-10 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

36 Loyola University 

Medical Center 

Hospital Two secondary chambers 

(1600°F), twin rotary atomizer scrubber using 50% caustic solution, and two demister pads 

WS State Plan 9/15/2002 

37 Parkview Hospital Hospital Secondary chamber and 

wet scrubber 

WS State Plan 3/31/2002 

38 South Bend Medical 

Foundation 

Hospital Secondary chamber and 

wet scrubber 

WS State Plan 3/31/2002 

39 Good Samaritan Hospital Hospital Secondary chamber and 

multi-chamber spray scrubber 

WS State Plan 3/31/2002 

40 Mayo Clinic, Waste 

Management Facility 

Hospital Secondary chamber 

(1800°F, 1 sec) and baghouse with lime and carbon injection 

DIFF Federal Plan 8/15/2001 

41 Fairfield Medical Center Hospital Secondary chamber 

(1800°F, 1 sec) and wet scrubber 

WS Federal Plan 9/15/2002 

42 MedCentral Health 

System, Mansfield Hospital 

Hospital Secondary chamber 

(1800°F, 2 sec) and baghouse with lime and carbon injection system 

DIFF Federal Plan 9/15/2002 

43 Medina General Hospital Hospital Secondary chamber 

(1800°F, 1 sec) and wet scrubber 

WS Federal Plan 9/15/2002 

44 Stericycle, Inc. Commercial Secondary chamber 

(1800°F, 2 sec), wet scrubber 

WS Federal Plan 9/15/2002 

45 Waste Management 

Resource Recovery & Recycling Center 

Unit 1 Commercial Secondary chamber, 

baghouse with virgin lime injection, urea injection, and activated carbon injection 

DIFF NSPS 

M-11 
No. Facility name 

Unit 

no. Facility type APCD description 

APCD 

code 

State Plan/ 

Federal 

Plan/NSPS 

Compliance 

date 

46 Waste Management 

Resource Recovery & Recycling Center 

Unit 2 Commercial Secondary chamber, 

baghouse with virgin lime injection, urea injection, and activated carbon injection 

DIFF NSPS 

47 University of Texas 

Medical Branch 

Hospital Secondary chamber, 

packed tower, and venturi scrubber with activated carbon injection 

WS Federal Plan 9/15/2002 

48 Stericycle, Inc. Commercial Secondary chamber 

(1800°F, 2 sec), wet scrubber 

WS State Plan 9/15/2002 

49 Rocky Mountain 

Laboratories 

Fed research Secondary chamber and 

wet scrubber 

WS State Plan 9/15/2002 

50 Healthcare 

Environmental Services Inc. 

Commercial Secondary chamber 

(1800°F) and dry scrubber/baghouse system with lime and carbon injection 

DIFF State Plan 9/15/2002 

51 Stericycle, Inc. Commercial Secondary chamber 

(1834°F), carbon injection system, ESP, dry scrubber, and wet gas absorber 

DIESP/ 

WS 

State Plan 9/15/2002 

52 Wyoming Medical 

Center 

Hospital Secondary chamber and 

wet scrubber 

WS State Plan 9/15/2002 

53 Kona Community 

Hospital 

Hospital Secondary chamber 

(1900°F, 2 sec), no APCD 

CC Federal Plan 8/15/2001 

54 Yukon-Kuskokwim 

Delta Regional Hospital 

Hospital Secondary chamber, no 

APCD 

CC Federal Plan 

M-12 
M-13 

Key: APCD = Air pollution control device CA = Carbon adsorber CC = Combustion control DI = Dry injection DIFF = Dry injection fabric filter E = Existing HMIWI ESP = Electrostatic precipitator FF = Fabric filter HEPA = High-efficiency particulate air HMIWI = Hospital/medical/infectious waste incinerator(s) L = Large HMIWI M = Medium HMIWI N = New HMIWI S = Small HMIWI SR = Small rural HMIWI WESP = Wet ESP WS = Wet scrubber 
United States 

Environmental Protection Agency 

Office of Air Quality Planning and Standards 

Sector Policies and Programs Division 

Research Triangle Park, NC 

Publication N