Date: February 1, 2013

Subject: Redline Version of the HMIWI Federal Plan Highlighting the Final Amendments

From: Amy Hambrick

OAQPS/SPPD (E143-03)

U.S. Environmental Protection Agency

Research Triangle Park, NC 27711

To: HMIWI Federal Plan Docket

The purpose of this memorandum is to present a redline version of 40 CFR part 62, subpart 

HHH, which shows the proposed amendments to the federal plan requirements for 

hospital/medical/infectious waste incinerators (HMIWI).
Subpart HHH—Federal Plan Requirements for 

Hospital/Medical/Infectious Waste Incinerators Constructed On Or

Before December 1, 2008

Applicability

§ 62.14400 Am I subject to this subpart?

(a) You are subject to this subpart if paragraphs (a)(1), 

(2)(i) or (ii), and (3) of this section are all true:

(1) You own or operate an HMIWI that is not covered by an 

EPA approved and effective State or Tribal plan;

(2)(i) Construction of the HMIWI commenced on or before 

June 20, 1996, or modification of the HMIWI commenced on or 

before March 16, 1998; or

(ii) Construction of the HMIWI commenced after June 20, 

1996 but no later than December 1, 2008, or modification of the 

HMIWI commenced after March 16, 1998 but no later than April 6, 

2010; and

(3) You do not meet any of the exemptions in paragraph (b) 

of this section.

(b) The following exemptions apply:

If you . . . And you . . . And you . . . Then you . . .

(1) Own or operate an 

HMIWI that combusts 

only pathological 

waste, low-level 

radioactive waste, 

and/or 

chemotherapeutic

waste (all defined in 

40 CFR 62.14490)

Notify the EPA 

Administrator (or 

delegated enforcement 

authority) of an 

exemption claim

Keep records on a 

calendar quarter basis 

of the periods of time 

when only pathological 

waste, low-level 

radioactive waste, 

and/or chemotherapeutic 

waste is combusted, and 

you submit such records 

to the EPA 

Are not subject to 

the other sections 

of this subpart 

during periods 

when only 

pathological, lowlevel radioactive, 

and/or 

chemotherapeutic 

wastes are 
Page 2 of 73

If you . . . And you . . . And you . . . Then you . . .

Administrator (or 

delegated enforcement 

authority) upon request

combusted.

(2) Own or operate a 

co-fired combustor 

(defined in 40 CFR 

62.14490)

Notify the EPA 

Administrator (or 

delegated enforcement 

authority) of an 

exemption claim and 

you provide an 

estimate of the 

relative weight of 

hospital waste, 

medical/infectious 

waste, and other fuels 

and/or wastes to be 

combusted

Keep records on a 

calendar quarter basis 

of the weight of 

hospital waste and 

medical/infectious 

waste combusted as well 

as the weight of all 

other fuels and wastes 

combusted at the cofired combustor, and 

these records reflect 

that the source 

continues to meet the 

definition of co-fired 

combustor in 40 CFR 

62.14490, and you 

submit such records to 

the EPA Administrator 

(or delegated 

enforcement authority) 

upon request

Are not subject to 

the other sections 

of this subpart.

(3) Own or operate a 

combustor that must 

have a permit under 

Section 3005 of the 

Solid Waste Disposal 

Act

Are not subject to 

this subpart.

(4) Own or operate a 

combustor which meets 

the applicability 

requirements of 40 

CFR part 60 subpart 

Cb, Ea, or Eb 

(standards or 

guidelines for 

certain municipal 

waste combustors)

Are not subject to 

this subpart.

(5) Own or operate a 

pyrolysis unit 

(defined in 40 CFR 

62.14490) processing 

hospital waste and/or 

medical/infectious 

waste

Are not subject to 

this subpart.

(6) Own or operate a 

cement kiln firing 

hospital waste and/or 

medical/infectious 

waste

Are not subject to 

this subpart.

(c) Owners or operators of sources that qualify for the 

exemptions in paragraphs (b)(1) or (b)(2) of this section must 
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submit records required to support their claims of exemption to 

the EPA Administrator (or delegated enforcement authority) upon 

request. Upon request by any person under the regulation at 

part 2 of this chapter (or a comparable law or regulation 

governing a delegated enforcement authority), the EPA 

Administrator (or delegated enforcement authority) must request 

the records in (b)(1) or (b)(2) from an owner or operator and 

make such records available to the requestor to the extent 

required by part 2 of this chapter (or a comparable law 

governing a delegated enforcement authority). Records required 

under paragraphs (b)(1) and (b)(2) of this section must be 

maintained by the source for a period of at least 5 years. 

Notifications of exemption claims required under paragraphs 

(b)(1) and (b)(2) of this section must be maintained by the EPA 

or delegated enforcement authority for as long as the source is 

operating under such exempt status. Any information obtained 

from an owner or operator of a source accompanied by a claim of 

confidentiality will be treated in accordance with the 

regulations in part 2 of this chapter (or a comparable law 

governing a delegated enforcement authority).

§ 62.14401 How do I determine if my HMIWI is covered by an 

approved and effective state or tribal plan?
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This part (40 CFR part 62) contains a list of all states 

and tribal areas with approved Clean Air Act (CAA) section 

111(d)/129 plans in effect. However, this part is only updated 

once a year. Thus, if this part does not indicate that your 

state or tribal area has an approved and effective plan, you 

should contact your state environmental agency's air director or 

your EPA Regional Office to determine if approval occurred since 

publication of the most recent version of this part. A state 

may also meet its CAA section 111(d)/129 obligations by 

submitting an acceptable written request for delegation of the 

federal plan that meets the requirements of this section. This 

is the only other option for a state to meet its 111(d)/129 

obligations. 

(a) An acceptable federal plan delegation request must 

include the following:

(1) A demonstration of adequate resources and legal 

authority to administer and enforce the federal plan.

(2) The items under § 60.25(a) and 60.39e(c).

(3) Certification that the hearing on the state delegation 

request, similar to the hearing for a state plan submittal, was 

held, 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.
Page 5 of 73

(4)A commitment to enter into a Memorandum of Agreement 

with the Regional Administrator who sets forth the terms, 

conditions, and effective date of the delegation and that serves 

as the mechanism for the transfer of authority. Additional 

guidance and information is given in the EPA’s Delegation 

Manual, Item 7–139, Implementation and Enforcement of 111(d)(2) 

and 111(d)(2)/ 129(b)(3) federal plans.

(b)A state with an already approved HMIWI CAA section 

111(d)/129 state plan is not precluded from receiving EPA 

approval of a delegation request for the revised federal plan,

providing the requirements of paragraph (a) of this section are 

met, and at the time of the delegation request, the state also 

requests withdrawal of the EPA’s previous state plan approval.

(c) A state’s CAA section 111(d)/129 obligations are 

separate from its obligations under Title V of the CAA.

§ 62.14402 If my HMIWI is not listed on the federal plan 

inventory, am I exempt from this subpart?

Not necessarily. Sources subject to this subpart include, 

but are not limited to, the inventory of sources listed in 

Docket EPA-HQ-OAR-2011-0405 for the federal plan. Review the 

applicability of §62.14400 to determine if you are subject to 

this subpart.

§ 62.14403 What happens if I modify an existing HMIWI?
Page 6 of 73

(a) If you commenced modification (defined in 40 CFR 

62.14490) of an existing HMIWI after April 6, 2010, you are 

subject to 40 CFR part 60, subpart Ec (40 CFR 60.50c through 

60.58c), as amended, and you are not subject to this subpart, 

except as provided in paragraph (b) of this section.

(b) If you made physical or operational changes to your 

existing HMIWI solely for the purpose of complying with this 

subpart, these changes are not considered a modification and you 

are not subject to 40 CFR part 60, subpart Ec (40 CFR 60.50c 

through 60.58c), as amended. You remain subject to this 

subpart.

Emission Limits

§ 62.14410 Are there different emission limits for different 

locations and sizes of HMIWI?

Yes, there are different emission limits for small rural, 

small, medium, and large HMIWI. To determine the size category 

of your HMIWI, consult the definitions in 40 CFR 62.14490.

§ 62.14411 What emission limits apply to my HMIWI?

You must operate your HMIWI in compliance with the emission 

limit requirements for your HMIWI size category listed in table 

1 of this subpart.

§ 62.14412 What stack opacity and visible emissions 

requirements apply?
Page 7 of 73

(a) Your HMIWI (regardless of size category) must not 

discharge into the atmosphere from the stack any gases that 

exhibit greater than 6 percent opacity (6-minute block average).

(b) Your HMIWI as defined in §62.14400(a)(2)(ii) and 

utilizing a large HMIWI must not discharge 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 40 CFR part 60, 

appendix A–7, except as provided in paragraphs (b)(1) and (2) of 

this section.

(1) The emissions limit specified in paragraph (b) of this 

section does not cover visible emissions discharged inside 

buildings or enclosures of ash conveying systems; however, the 

emissions limit does cover visible emissions discharged to the 

atmosphere from buildings or enclosures of ash conveying 

systems.

(2) The provisions specified in paragraph (b) of this 

section do not apply during maintenance and repair of ash 

conveying systems. Maintenance and/or repair must not exceed 10 

operating days per calendar quarter unless you obtain written 

approval from the State agency establishing a date when all 
Page 8 of 73

necessary maintenance and repairs of ash conveying systems are 

to be completed.

§ 62.14413 When do the emissions limits and stack opacity and 

visible emissions requirements apply?

The emissions limits, stack opacity, and visible emissions 

requirements of this subpart apply at all times.

Operator Training and Qualification

§ 62.14420 Am I required to have a trained and qualified 

operator?

You must have a fully trained and qualified HMIWI operator, 

either at your facility or able to be at your facility 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.

§ 62.14421 How does an operator become trained and qualified?

(a) The HMIWI operator can obtain training and 

qualification through a State-approved program or as provided in 

paragraph (b) of this section.

(b) If there are no State-approved training and 

qualification programs available or if your operator does not 

want to participate in a State-approved program, then your 

operator must complete a training course that includes the 
Page 9 of 73

requirements in §62.14422 and satisfy the qualification 

requirements in §62.14423.

§ 62.14422 What are the requirements for a training course 

that is not part of a State-approved program?

A training course must include:

(a) Twenty-four hours of training that includes all of the 

following subjects:

(1) Environmental concerns, including pathogen destruction 

and types of emissions;

(2) Basic combustion principles, including products of 

combustion;

(3) Operation of the type of incinerator to be used by the 

operator, including proper startup, waste charging, and shutdown 

procedures;

(4) Combustion controls and monitoring;

(5) Operation of air pollution control equipment and 

factors affecting performance (if applicable);

(6) 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);

(7) Inspection and maintenance of the HMIWI, air pollution 

control devices, and continuous emission monitoring systems;
Page 10 of 73

(8) Actions to correct malfunctions and conditions that may 

lead to malfunction;

(9) Bottom and fly ash characteristics and handling 

procedures;

(10) Applicable Federal, State, and local regulations;

(11) Work safety procedures;

(12) Prestartup inspections; 

(13) Recordkeeping requirements; and

(14) Training in waste segregation according to 

§62.14430(c)

(b) An examination designed and administered by the 

instructor; and

(c) Reference material distributed to the attendees 

covering the course topics.

§ 62.14423 What are the qualification requirements for 

operators who do not participate in a State-approved program?

(a) Operators who do not participate in a State-approved 

program must satisfy paragraphs (a)(1) and (2) of this section:

(1) The operator must complete a training course that 

satisfies the requirements in §62.14422; and

(2) The operator must have 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 
Page 11 of 73

the observation and supervision of two qualified HMIWI 

operators.

(b) The operator's qualification is valid after paragraphs 

(a)(1) and (2) of this section are completed.

(c) To remain qualified, the operator must complete and 

pass an annual review or refresher course of at least 4 hours 

covering, at a minimum, the following:

(1) Update of regulations;

(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.

(d) If the operator's qualification lapses, he or she must

renew it by one of the following methods:

(1) For a lapse of less than 3 years, complete and pass a 

standard annual refresher course described in paragraph (c) of 

this section;

(2) For a lapse of 3 years or more, complete and pass a 

training course with the minimum criteria described in 

§62.14422.
Page 12 of 73

§ 62.14424 What documentation must I maintain onsite?

(a) You must maintain the following at the facility:

(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) Procedures for startup, shutdown, and malfunction;

(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 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.

(b) You must keep the information listed in paragraph (a) 

of this section in a readily accessible location for all HMIWI 

operators. This information, along with records of training, 

must be available for inspection by the EPA or its delegated 

enforcement agent upon request.
Page 13 of 73

§ 62.14425 When must I review the documentation?

(a) You must establish a program for reviewing the 

information listed in §62.14424 annually with each HMIWI 

operator (defined in §62.14490).

(b) You must conduct your initial review of the information 

listed in §62.14424 by [date 6 months after publication of final 

rule], or prior to assumption of responsibilities affecting 

HMIWI operation, whichever is later.

(c) You must conduct subsequent reviews of the information 

listed in §62.14424 annually.

Waste Management Plan

§ 62.14430 Must I prepare a waste management plan?

Yes. All HMIWI owners or operators must have a waste 

management plan.

§ 62.14431 What must my waste management plan include?

(a) Your waste management plan must identify both the 

feasibility of, and the approach for, separating certain 

components of solid waste from the health care waste stream in 

order to reduce the amount of toxic emissions from incinerated 

waste. The waste management plan you develop may address, 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); 
Page 14 of 73

segregation of non-recyclable wastes (e.g., polychlorinated 

biphenyl-containing waste, pharmaceutical waste, and mercurycontaining waste such as dental waste); and purchasing recycled 

or recyclable products. Your 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. When you develop your waste management 

plan, 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 potential environmental or energy 

impacts they might have. In developing your waste management 

plan, you must consider the American Hospital Association (AHA)

publication titled “Ounce of Prevention: Waste Reduction 

Strategies for Health Care Facilities.” This publication (AHA 

Catalog No. 057007) is available for purchase from AHA Services, 

Inc., Post Office Box 933283, Atlanta, Georgia 31193-3283.

(b) If you own or operate commercial HMIWI, you must 

conduct training and education programs in waste segregation for 

each of your waste generator clients and ensure that each client 

prepares its own waste management plan that includes, but is not 

limited to, the provisions listed in this section.
Page 15 of 73

(c) If you own or operate commercial HMIWI, you must 

conduct training and education programs in waste segregation for 

your HMIWI operators. 

§ 62.14432 When must my waste management plan be completed?

As specified in §§62.14463 and 62.14464, you must submit 

your waste management plan with your initial report, which is 

due 60 days after you demonstrate initial compliance with the 

amended emissions limits, by conducting an initial performance 

test or submitting the results of previous emissions tests, 

provided the conditions in §62.14451(e) are met.

Inspection Requirements

§ 62.14440 Which HMIWI are subject to inspection requirements?

(a) All HMIWI, including small rural HMIWI (defined in 

§62.14490) and each HMIWI (subject to emissions limits and 

visible emissions requirements in §62.14411 and §62.14412), are 

subject to the HMIWI equipment inspection requirements.

(b) All HMIWI equipped with one or more air pollution 

control devices are subject to the air pollution control device 

inspection requirements.
Page 16 of 73

§ 62.14441 When must I inspect my HMIWI equipment and air 

pollution control devices?

(a) You must inspect your large, medium, small or small 

rural HMIWI equipment by [date 1 year after publication of final 

rule].

(b) You must conduct inspections of your large, medium, 

small or small rural HMIWI equipment as outlined in §62.14442(a)

annually (no more than 12 months following the previous annual

HMIWI equipment inspection).

(c) You must inspect the air pollution control devices on 

your large, medium, small or small rural HMIWI by [date 1 year 

after publication of final rule].

(d) You must conduct the air pollution control device 

inspections on your large, medium, small or small rural HMIWI as 

outlined in §62.14442(b) annually (no more than 12 months 

following the previous annual air pollution control device

inspection).

§ 62.14442 What must my inspections include?

(a) At a minimum, you must do the following during your 

HMIWI equipment inspection:

(1) Inspect all burners, pilot assemblies, and pilot 

sensing devices for proper operation, and clean pilot flame 

sensor as necessary;
Page 17 of 73

(2) Check for proper adjustment of primary and secondary 

chamber combustion air, and adjust as necessary;

(3) Inspect hinges and door latches, and lubricate as 

necessary;

(4) Inspect dampers, fans, and blowers for proper 

operation;

(5) Inspect HMIWI door and door gaskets for proper sealing;

(6) Inspect motors for proper operation;

(7) Inspect primary chamber refractory lining, and clean 

and repair/replace lining as necessary;

(8) Inspect incinerator shell for corrosion and/or hot 

spots;

(9) Inspect secondary/tertiary chamber and stack, and clean 

as necessary;

(10) Inspect mechanical loader, including limit switches, 

for proper operation, if applicable;

(11) Visually inspect waste bed (grates), and repair/ seal, 

as necessary;

(12) For the burn cycle that follows the inspection, 

document that the incinerator is operating properly and make any 

necessary adjustments;

(13) Inspect air pollution control device(s) for proper 

operation, if applicable;
Page 18 of 73

(14) Inspect waste heat boiler systems to ensure proper 

operation, if applicable;

(15) Inspect bypass stack components;

(16) Ensure proper calibration of thermocouples, sorbent 

feed systems, and any other monitoring equipment; (17) Include 

inspection elements according to manufacturer's recommendations; 

and

(18) Generally observe that the equipment is maintained in 

good operating condition.

(b) At a minimum, you must do the following during your air 

pollution control device inspection:

(1) Inspect air pollution control device(s) for proper 

operation, if applicable;

(2) Ensure proper calibration of thermocouples, sorbent 

feed systems and any other monitoring equipment; 

(3) Include inspection elements according to manufacturer's 

recommendations; and

(4) Generally observe that the equipment is maintained in 

good operating condition.

§ 62.14443 When must I do repairs?

(a) You must complete any necessary repairs to the HMIWI

equipment within 10 operating days of the HMIWI equipment 

inspection unless you obtain written approval from the EPA 
Page 19 of 73

Administrator (or delegated enforcement authority) establishing 

a different date when all necessary repairs of your HMIWI

equipment must be completed.

(b) You must complete any necessary repairs to the air 

pollution control device within 10 operating days of the air 

pollution control device inspection unless you obtain written 

approval from the EPA Administrator (or delegated enforcement 

authority) establishing a different date when all necessary 

repairs of your air pollution control device must be completed.

During the time that you conduct repairs to your air pollution 

control device, all emissions standards remain in effect 

according to § 62.14413. 

Performance Testing and Monitoring Requirements

§ 62.14450 [Reserved]

§ 62.14451 What are the testing requirements?

(a) Except as specified in paragraph (e) of this section, 

you must conduct an initial performance test for PM, opacity, 

CO, dioxin/furan, HCl, Pb, Cd, Hg, SO2, NOX, and fugitive ash 

emissions using the test methods and procedures outlined in 

§62.14452.

(b) After the initial performance test is completed or is 

required to be completed under §62.14470, whichever date comes 

first, you must:
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(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 §62.14452.

(2) Determine compliance with the PM, CO, and HCl emission 

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 §62.14452. If 

all three performance tests over a 3-year period indicate 

compliance with the emission limit for a pollutant (PM, CO, or 

HCl), you may forego a performance test for that pollutant for 

the next 2 years. At a minimum, you must conduct a performance 

test for PM, CO, and HCl 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 emission limit for a pollutant (PM, CO, or HCl), you 

may forego a performance test for that pollutant for an 

additional 2 years. If any performance test indicates 

noncompliance with the respective emission limit, you must 

conduct a performance test for that pollutant annually until all 

annual performance tests over a 3-year period indicate 

compliance with the emission limit.
Page 21 of 73

(3) If you use a large HMIWI that commenced construction 

or modification according to §62.14400(a)(2)(ii), 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 

40 CFR part 60, appendix A–7 on an annual basis (no more than 12 

months following the previous performance test).

(c) The 2,000 lb/wk limitation for small rural HMIWI does 

not apply during performance tests.

(d) The EPA Administrator may request a repeat performance 

test at any time.

(e) You may use the results of previous emissions tests to 

demonstrate compliance with the emissions limits, provided that 

the conditions in paragraphs (e)(1) through (3) of this section 

are met:

(1) Your previous emissions tests must have been conducted 

using the applicable procedures and test methods listed in 

§62.14452. Previous emissions test results obtained using EPAaccepted voluntary consensus standards are also acceptable.

(2) The HMIWI at your facility must 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 
Page 22 of 73

test(s), and the HMIWI may not have been modified such that 

emissions would be expected to exceed the results from previous 

emissions test(s).

(3) The previous emissions test(s) must have been conducted 

in 1996 or later.

§ 62.14452 What test methods and procedures must I use?

You must use the following test methods and procedures to 

conduct performance tests to determine compliance with the 

emission limits:

(a) All performance tests must consist of a minimum of 

three test runs conducted under representative operating 

conditions;

(b) The minimum sample time must be 1 hour per test run 

unless otherwise indicated in this section;

(c) You must use EPA Reference Method 1 of 40 CFR part 60, 

appendix A-1 to select the sampling location and number of 

traverse points;

(d) You must use EPA Reference Method 3, 3A or 3B of 40 CFR 

part 60, appendix A-2 for gas composition analysis, including 

measurement of oxygen concentration. You must use EPA Reference 

Method 3, 3A or 3B of 40 CFR part 60, appendix A-2

simultaneously with each reference method. You may use ASME 
Page 23 of 73

PTC-19-10-1981-Part 10 (incorporated by reference in 40 CFR 

60.17) as an alternative to EPA Reference Method 3B;

(e) You must adjust pollutant concentrations to 7 percent 

oxygen using the following equation:

Where:

Cadj= pollutant concentration adjusted to 7 percent oxygen;

Cmeas= pollutant concentration measured on a dry basis at standard 

conditions

(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 at standard 

conditions, percent.

(f) You must use EPA Reference Method 5 of 40 CFR part 60, 

appendix A-3 or Method 26A or Method 29 of 40 CFR part 60, 

appendix A-8 to measure particulate matter (PM) emissions. You 

may use bag leak detection systems, as specified in 

§62.14454(e), or PM continuous emissions monitoring systems 

(CEMS), as specified in paragraph (o) of this section, as an 

alternative to demonstrate compliance with the PM emissions 

limit;
Page 24 of 73

(g) You must use EPA Reference Method 6 or 6C of 40 CFR 

part 60, appendix A-4 to measure SO2 emissions;

(h) You must use EPA Reference Method 7 or 7E of 40 CFR 

part 60, appendix A-4 to measure NOX emissions;

(i) You must use EPA Reference Method 9 of 40 CFR part 60, 

appendix A-4 to measure stack opacity. You may use bag leak 

detection systems, as specified in §62.14454(e), or PM CEMS, as 

specified in paragraph (o) of this section, as an alternative to 

demonstrate compliance with the opacity requirements;

(j) You must use EPA Reference Method 10 or 10B of 40 CFR 

part 60, appendix A-4 to measure the CO emissions. You may use 

CO CEMS, as specified in paragraph (o) of this section, as an 

alternative to demonstrate compliance with the CO emissions 

limit;

(k) You must use EPA Reference Method 23 of 40 CFR part 60, 

appendix A-7 to measure total dioxin/furan emissions. The 

minimum sample time must be 4 hours per test run. You may elect 

to sample dioxins/furans by installing, calibrating, maintaining

and operating a continuous automated sampling system, as 

specified in paragraph (p) of this section, as an alternative to 

demonstrate compliance with the dioxin/furan emissions limit.

If you have selected the toxic equivalency (TEQ) standards for 
Page 25 of 73

dioxin/furans under §62.14411, you must use the following 

procedures to determine compliance:

(1) Measure the concentration of each dioxin/furan tetrathrough octa-congener emitted using EPA Reference Method 23 of 

40 CFR part 60, appendix A-7;

(2) For each dioxin/furan congener measured in accordance 

with paragraph (k)(1) of this section, multiply the congener 

concentration by its corresponding TEQ factor specified in Table 

2 of this subpart;

(3) Sum the products calculated in accordance with 

paragraph (k)(2) of this section to obtain the total 

concentration of dioxins/furans emitted in terms of toxic 

equivalency.

(l) You must use EPA Reference Method 26 or 26A of 40 CFR 

part 60, appendix A-8 to measure HCl emissions. You may use HCl 

CEMS as an alternative to demonstrate compliance with the HCl 

emissions limit;

(m) You must use EPA Reference Method 29 of 40 CFR part 60, 

appendix A-8 to measure Pb, Cd and Hg emissions. You may use 

ASTM D6784-02 (incorporated by reference in 40 CFR 60.17) as an 

alternative to EPA Reference Method 29 for measuring Hg 

emissions. You may also use Hg CEMS, as specified in paragraph 

(o) of this section, or a continuous automated sampling system 
Page 26 of 73

for monitoring Hg emissions, as specified in paragraph (q) of 

this section, as an alternative to demonstrate compliance with 

the Hg emissions limit. You may use multi-metals CEMS, as 

specified in paragraph (o) of this section, as an alternative to 

EPA Reference Method 29 to demonstrate compliance with the Pb, 

Cd or Hg emissions limits;

(n) You must use EPA Reference Method 22 of 40 CFR part 60, 

appendix A–7 to measure fugitive ash emissions and determine 

compliance with the fugitive ash emissions limit, as applicable,

under §60.52c(c). The minimum observation time must be a series 

of three 1-hour observations.

(o) If you are using a CEMS to demonstrate compliance with 

any of the emissions limits under §§62.14411 or 62.14412, you:

(1) Must determine compliance with the appropriate 

emissions limit(s) using a 12-hour rolling average, calculated 

as specified in section 12.4.1 of EPA Reference Method 19 of 40 

CFR part 60, appendix A-7. Performance tests using EPA 

Reference Methods are not required for pollutants monitored with 

CEMS.

(2) Must operate a CEMS to measure oxygen concentration, 

adjusting pollutant concentrations to 7 percent oxygen as 

specified in paragraph (e) of this section.
Page 27 of 73

(3) Must operate all CEMS in accordance with the applicable 

procedures under appendices B and F of 40 CFR part 60. For 

those CEMS for which performance specifications have not yet 

been promulgated (HCl, multi-metals), this option 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.

(4) May substitute use of a CO CEMS for the CO annual 

performance test and minimum secondary chamber temperature to 

demonstrate compliance with the CO emissions limit.

(5) May 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.

(6) May 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.

(p) If you are using a continuous automated sampling system 

to demonstrate compliance with the dioxin/furan emissions 

limits, you must record the output of the system and analyze the 

sample according to EPA Reference Method 23 of 40 CFR part 60, 

appendix A–7. This option to use a continuous automated 
Page 28 of 73

sampling system takes effect on the date a final performance 

specification applicable to dioxin/furan from monitors is 

published in the Federal Register or the date of approval of a 

site-specific monitoring plan. If you elect to continuously 

sample dioxin/furan emissions instead of sampling and testing 

using EPA Reference Method 23 of 40 CFR part 60, appendix A–7, 

you must install, calibrate, maintain and operate a continuous 

automated sampling system and comply with the requirements 

specified in 40 CFR 60.58b(p) and (q) of subpart Eb.

(q) If you are using a continuous automated sampling system 

to demonstrate compliance with the Hg emissions limits, you must 

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. If you elect to continuously 

sample Hg emissions instead of sampling and testing using EPA 

Reference Method 29 of 40 CFR part 60, appendix A–8, or an 

approved alternative method for measuring Hg emissions, you must 

install, calibrate, maintain and operate a continuous automated 
Page 29 of 73

sampling system and comply with the requirements specified in 40 

CFR 60.58b(p) and (q) of subpart Eb.

(r) Use of the bypass stack during a performance test will 

invalidate the performance test.

§ 62.14453 What must I monitor?

(a) If your HMIWI uses combustion control only, or your 

HMIWI is equipped with a dry scrubber followed by a fabric 

filter (FF), a wet scrubber, a dry scrubber followed by a FF and 

wet scrubber, or a selective noncatalytic reduction (SNCR)

system:

(1) You must establish the appropriate maximum and minimum 

operating parameters, indicated in Table 3, as site-specific 

operating parameters during the initial performance test to 

determine compliance with the emission limits; and

(2) After the date on which the initial performance test is 

completed or is required to be completed under §62.14470, 

whichever comes first, your HMIWI must not operate above any of 

the applicable maximum operating parameters or below any of the 

applicable minimum operating parameters listed in Table 3 and 

measured as 3-hour rolling averages (calculated each hour as the 

average of the previous 3 operating hours), at all times except 

during performance tests.
Page 30 of 73

(b) If you are using an air pollution control device other 

than a dry scrubber followed by a FF, a wet scrubber, a dry 

scrubber followed by a fabric filter and a wet scrubber, or a 

SNCR system to comply with the emissions limits under 

§62.14411, you must petition the EPA Administrator for sitespecific operating parameters to be established during the 

initial performance test and you must continuously monitor those 

parameters thereafter. You may not conduct the initial 

performance test until the EPA Administrator has approved the 

petition.

§ 62.14454 How must I monitor the required parameters?

(a) Except as provided in §§62.14452(o) through (q), you 

must 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 of 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 

the operating parameters at the frequencies indicated in Table 3 

of this subpart at all times. For charge rate, the device must 

measure and record the date, time and weight of each charge fed 

to the HMIWI. This must be done automatically, meaning that the 

only intervention from an operator during the process would be 
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to load the charge onto the weighing device. For batch HMIWI, 

the maximum charge rate is measured on a daily basis (the amount 

of waste charged to the unit each day).

(b) For all HMIWI, you must install, calibrate (to 

manufacturers' specifications), maintainand operate a device or 

method for measuring the use of the bypass stack, including the 

date, time and duration of such use.

(c) For all HMIWI, if you are using controls other than a 

dry scrubber followed by a FF, a wet scrubber, a dry scrubber 

followed by a FF and a wet scrubber, or a SNCR system to comply 

with the emissions limits under §62.14411, you must install, 

calibrate (to manufacturers' specifications), maintain and 

operate the equipment necessary to monitor the site-specific 

operating parameters developed pursuant to §62.14453(b).

(d) You must 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 must be obtained for 75 percent of the operating 

hours per day for 90 percent of the operating days per calendar 

quarter that your HMIWI is combusting hospital waste and/or 

medical/infectious waste.

(e) If you use an air pollution control device that 

includes a FF and are not demonstrating compliance using PM 
Page 32 of 73

CEMS, you must determine compliance with the PM emissions limit 

using a bag leak detection system and meet the requirements in 

paragraphs (e)(1) through (e)(12) of this section for each bag 

leak detection system.

(1) Each triboelectric bag leak detection system mustbe 

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 must be installed, operated, calibrated and 

maintained in a manner consistent with the manufacturer's 

written specifications and recommendations.

(2) The bag leak detection system must 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 must provide an 

output of relative PM loadings.
Page 33 of 73

(4) The bag leak detection system must be equipped with a 

device to continuously record the output signal from the sensor.

(5) The bag leak detection system must 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 must be located where it is easily heard by 

plant operating personnel.

(6) For positive pressure FF systems, a bag leak detector 

must be installed in each baghouse compartment or cell.

(7) For negative pressure or induced air FF, the bag leak 

detector must be installed downstream of the FF.

(8) Where multiple detectors are required, the system's 

instrumentation and alarm may be shared among detectors.

(9) The baseline output must 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 
Page 34 of 73

adjustment follows a complete FF inspection that demonstrates 

that the FF is in good operating condition. Each adjustment 

must 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 FF 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 FF 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.

§ 62.14455 What if my HMIWI goes outside of a parameter limit?

(a) Operation above the established maximum or below the 

established minimum operating parameter(s) constitutes a 

violation of established operating parameter(s). Operating 

parameter limits do not apply during performance tests.

(b) Except as provided in paragraph (g) or (h) of this 

section, if your HMIWI uses combustion control only,

And your HMIWI . . .

Then you are in 

violation of . . .
Page 35 of 73

Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum secondary chamber temperature (3-

hour rolling average) simultaneously

The PM, CO, and 

dioxin/furan 

emissions limits.

(c) Except as provided in paragraph (f) or (g) of this 

section, if your HMIWI is equipped with a dry scrubber followed 

by a FF:

And your HMIWI . . .

Then you are in 

violation of . . .

(1) Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum secondary chamber temperature (3-hour 

rolling average) simultaneously

The CO emissions

limit.

(2) Operates above the maximum FF inlet temperature (3-hour 

rolling average), above the maximum charge rate (3-hour rolling 

average for continuous and intermittent HMIWI, daily average for 

batch HMIWI), and below the minimum dioxin/furan sorbent flow rate 

(3-hour rolling average) simultaneously

The dioxin/furan 

emissions limit.

(3) Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum HCl sorbent flow rate (3-hour rolling 

average) simultaneously

The HCl emissions

limit.

(4) Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum Hg sorbent flow rate (3-hour rolling 

average) simultaneously

The Hg emissions

limit.

(5) Uses the bypass stack The PM, 

dioxin/furan, HCl, 

Pb, Cd, and Hg 

emissions limits.

(6) Operates above the CO emissions limit as measured by a CO 

CEMS, as specified in §62.14452(o)

The CO emissions

limit.

(7) Uses a bag leak detection system, as specified in 

§62.14454(e), to demonstrate compliance with the PM emissions 

limit and either fails to initiate corrective action within 1 hour 

of a bag leak detection system alarm or fails to operate and 

maintain the FF such that the alarm is not engaged for more than 5 

percent of the total operating time in a 6-month block reporting 

period

The PM emissions 

limit.

a

(8) Uses a bag leak detection system, as specified in 

§62.14454(e), to demonstrate compliance with the opacity limit and 

either fails to initiate corrective action within 1 hour of a bag 

leak detection system alarm or fails to operate and maintain the 

FF such that the alarm is not engaged for more than 5 percent of 

the total operating time in a 6-month block reporting period

The opacity limit.a
Page 36 of 73

And your HMIWI . . .

Then you are in 

violation of . . .

(9) Operates above the PM emissions limit as measured by a PM

CEMS, as specified in §62.14452(o)

The PM emissions

limit.

(10) Operates above the HCl emissions limit as measured by an HCl

CEMS, as specified in §62.14452(o)

The HCl emissions

limit.

(11) Operates above the Pb emissions limit as measured by a multimetals CEMS, as specified in §62.14452(o)The Pb emissions 

limit.

(12) Operates above the Cd emissions limit as measured by a multimetals CEMS, as specified in §62.14452(o)The Cd emissions 

limit.

(13) Operates above the Hg emissions limit as measured by a multimetals CEMS, as specified in §62.14452(o)The Hg emissions 

limit

(14) Operates above the dioxin/furan emissions limit as measured 

by a continuous automated sampling system, as specified in 

§62.14452(p)

The dioxin/furan 

emissions limit.

(15) Operates above the Hg emissions limit as measured by a 

continuous automated sampling system, as specified in §62.14452(q)

The Hg emissions 

limit.

a If inspection of the FF 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.

(d) Except as provided in paragraph (g) or (h) of this 

section, if your HMIWI is equipped with a wet scrubber:

And your HMIWI . . .

Then you are in 

violation of . . .

(1) Operates above the maximum charge rate (3-hour rolling 

average for continuous and intermittent HMIWI, daily average for 

batch HMIWI) and below the minimum secondary chamber temperature 

(3-hour rolling average) simultaneously

The CO emissions

limit.

(2) Operates above the maximum charge rate (3-hour rolling 

average for continuous and intermittent HMIWI, daily average for 

batch HMIWI) and below the minimum pressure drop across the wet 

scrubber (3-hour rolling average) or below the minimum 

horsepower or amperage to the system (3-hour rolling average) 

simultaneously

The PM emissions

limit.

(3) Operates above the maximum charge rate (3-hour rolling 

average for continuous and intermittent HMIWI, daily average for 

batch HMIWI), below the minimum secondary chamber temperature 

(3-hour rolling average), and below the minimum scrubber liquor 

flow rate (3-hour rolling average) simultaneously

The dioxin/furan 

emissions limit.

(4) Operates above the maximum charge rate (3-hour rolling The HCl emissions
Page 37 of 73

average for continuous and intermittent HMIWI, daily average for 

batch HMIWI) and below the minimum scrubber liquor pH (3-hour 

rolling average) simultaneously

limit.

(5) Operates above the maximum flue gas temperature (3-hour 

rolling average) and above the maximum charge rate (3-hour 

rolling average for continuous and intermittent HMIWI, daily 

average for batch HMIWI) simultaneously

The Hg emissions

limit.

(6) Uses the bypass stack The PM, dioxin/furan, 

HCl, Pb, Cd, and Hg 

emissions limits.

(7) Operates above the CO emissions limit as measured by a CO 

CEMS, as specified in §62.14452(o) 

The CO emissions 

limit.

(8) Operates above the PM emissions limit as measured by a PM 

CEMS, as specified in §62.14452(o)

The PM emissions 

limit.

(9) Operates above the HCl emissions limit as measured by an HCl 

CEMS, as specified in §62.14452(o)

The HCl emissions 

limit.

(10) Operates above the Pb emissions limit as measured by a 

multi-metals CEMS, as specified in §62.14452(o)

The Pb emissions 

limit.

(11) Operates above the Cd emissions limit as measured by a 

multi-metals CEMS, as specified in §62.14452(o)

The Cd emissions 

limit.

(12) Operates above the Hg emissions limit as measured by a 

multi-metals CEMS, as specified in §62.14452(o)

The Hg emissions 

limit.

(13) Operates above the dioxin/furan emissions limit as measured 

by a continuous automated sampling system, as specified in 

§62.14452(p)

The dioxin/furan 

emissions limit.

(14) Operates above the Hg emissions limit as measured by a 

continuous automated sampling system, as specified in 

§62.14452(q)

The Hg emissions 

limit.

(e) Except as provided in paragraph (g) or (h) of this 

section, if your HMIWI is equipped with a dry scrubber followed 

by a FF and a wet scrubber:
Page 38 of 73

And your HMIWI . . .

Then you are in 

violation of . . .

(1) Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum secondary chamber temperature (3-hour 

rolling average) simultaneously

The CO emissions

limit.

(2) Operates above the maximum fabric filter inlet temperature (3-

hour rolling average), above the maximum charge rate (3-hour 

rolling average for continuous and intermittent HMIWI, daily 

average for batch HMIWI), and below the minimum dioxin/furan 

sorbent flow rate (3-hour rolling average) simultaneously

The dioxin/furan 

emissions limit.

(3) Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum scrubber liquor pH (3-hour rolling 

average) simultaneously

The HCl emissions

limit.

(4) Operates above the maximum charge rate (3-hour rolling average 

for continuous and intermittent HMIWI, daily average for batch 

HMIWI) and below the minimum Hg sorbent flow rate (3-hour rolling 

average) simultaneously

The Hg emissions

limit.

(5) Uses the bypass stack The PM, dioxin/

furan, HCl, Pb, Cd, 

and Hg emissions

limits.

(6) Operates above the CO emissions limit as measured by a CO 

CEMS, as specified in §62.14452(o) 

The CO emissions 

limit.

(7) Uses a bag leak detection system, as specified in 

§62.14454(e), to demonstrate compliance with the PM emissions 

limit and either fails to initiate corrective action within 1 hour 

of a bag leak detection system alarm or fails to operate and 

maintain the FF such that the alarm is not engaged for more than 5 

percent of the total operating time in a 6-month block reporting 

period

The PM emissions 

limit.a

(8) Uses a bag leak detection system, as specified in 

§62.14454(e), to demonstrate compliance with the opacity limit and 

either fails to initiate corrective action within 1 hour of a bag 

leak detection system alarm or fails to operate and maintain the 

FF such that the alarm is not engaged for more than 5 percent of 

the total operating time in a 6-month block reporting period

The opacity limit.a

(9) Operates above the PM emissions limit as measured by a PM 

CEMS, as specified in §62.14452(o)

The PM emissions 

limit.

(10) Operates above the HCl emissions limit as measured by an HCl 

CEMS, as specified in §62.14452(o)

The HCl emissions 

limit.

(11) Operates above the Pb emissions limit as measured by a multimetals CEMS, as specified in §62.14452(o)The Pb emissions 

limit.

(12) Operates above the Cd emissions limit as measured by a multimetals CEMS, as specified in §62.14452(o)The Cd emissions 

limit.

(13) Operates above the Hg emissions limit as measured by a multimetals CEMS, as specified in §62.14452(o)The Hg emissions 

limit

(14) Operates above the dioxin/furan emissions limit as measured 

by a continuous automated sampling system, as specified in 

§62.14452(p)

The dioxin/furan 

emissions limit.
Page 39 of 73

And your HMIWI . . .

Then you are in 

violation of . . .

(15) Operates above the Hg emissions limit as measured by a 

continuous automated sampling system, as specified in §62.14452(q)

The Hg emissions 

limit.

a If inspection of the FF 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.

(f) Except as provided in paragraph (g) or (h) of this 

section, if your HMIWI is equipped with a SNCR system:

And your HMIWI . . .

Then you are in 

violation of . . .

Operates above the maximum charge rate (3-hour rolling average for 

continuous and intermittent HMIWI, daily average for batch HMIWI), 

below the minimum secondary chamber temperature (3-hour rolling 

average), and below the minimum reagent flow rate (3-hour rolling 

average) simultaneously

The NOX emissions 

limit.

(g) You may conduct a repeat performance test within 30 

days of violation of applicable operating parameter(s) to 

demonstrate that your HMIWI is not in violation of the 

applicable emissions limit(s). You must conduct repeat 

performance tests pursuant to this paragraph using the identical 

operating parameters that indicated a violation under paragraph 

(b), (c), (d), (e) or (f) of this section.(h) If you are using a 

CEMS to demonstrate compliance with any of the emissions limits 

in table 1 of this subpart or §62.14412, and your CEMS indicates 

compliance with an emissions limit during periods when operating 

parameters indicate a violation of an emissions limit under 

paragraphs (b), (c), (d), (e), or (f) of this section, then you 

are considered to be in compliance with the emissions limit. 
Page 40 of 73

You need not conduct a repeat performance test to demonstrate 

compliance.

(i) You may conduct a repeat performance test in accordance 

with §62.14452 at any time to establish new values for the 

operating parameters.

Reporting and Recordkeeping Requirements

§ 62.14460 What records must I maintain?

You must maintain the following:

(a) Calendar date of each record;

(b) Records of the following data:

(1) Concentrations of any pollutant listed in table 1,

measurements of opacity and visible ash;

(2) The HMIWI charge dates, times, and weights and hourly 

charge rates;

(3) Fabric filter inlet temperatures during each minute of 

operation, as applicable;

(4) Amount and type of dioxin/furan sorbent used during 

each hour of operation, as applicable;

(5) Amount and type of Hg sorbent used during each hour of 

operation, as applicable;

(6) Amount and type of HCl sorbent used during each hour of 

operation, as applicable;
Page 41 of 73

(7) Amount and type of NOX reagent used during each hour of 

operation, as applicable;

(8) Secondary chamber temperatures recorded during each 

minute of operation;

(9) Liquor flow rate to the wet scrubber inlet during each 

minute of operation, as applicable,

(10) Horsepower or amperage to the wet scrubber during each 

minute of operation, as applicable;

(11) Pressure drop across the wet scrubber system during 

each minute of operation, as applicable;

(12) Temperature at the outlet from the wet scrubber during 

each minute of operation, as applicable;

(13) The pH at the inlet to the wet scrubber during each 

minute of operation, as applicable;

(14) Records of the annual equipment inspections, any 

required maintenance, and any repairs not completed within 10 

operating days of an inspection or the time frame established by 

the EPA Administrator or delegated enforcement authority, as 

applicable;

(15) Records indicating use of the bypass stack, including 

dates, times, and durations; and
Page 42 of 73

(16) All operating parameter data collected, if you are 

complying by monitoring site-specific operating parameters under 

§62.14453(b).

(17) Concentrations of CO, PM, HCl, Pb, Cd, Hg, and

dioxin/furan, as applicable, as determined by the CEMS or 

continuous automated sampling system, as applicable.

(18) 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.

(19) 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.

(c) Identification of calendar days for which data on 

emissions rates or operating parameters specified under 

paragraph (b)(1) through (19) of this section were not obtained, 

with an identification of the emissions rates or operating 

parameters not measured, reasons for not obtaining the data, and 

a description of corrective actions taken;

(d) Identification of calendar days, times and durations of 

malfunctions, and a description of the malfunction and the 

corrective action taken.
Page 43 of 73

(e) Identification of calendar days for which data on 

emissions rates or operating parameters specified under 

paragraphs (b)(1) through (19) of this section exceeded the 

applicable limits, with a description of the exceedances reasons 

for such exceedances, and a description of corrective actions 

taken.

(f) 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, including sample calculations, of how 

the operating parameters were established or re-established, if

applicable.

(g) Records showing the names of HMIWI operators who have 

completed review of the documentation in §62.14424 as required 

by §62.14425, including the date of the initial review and all 

subsequent annual reviews;

(h) 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;

(i) Records showing the names of the HMIWI operators who 

have met the criteria for qualification under §62.14423 and the 

dates of their qualification; and
Page 44 of 73

(j) Records of calibration of any monitoring devices as 

required under §62.14454.

§ 62.14461 For how long must I maintain records?

You must maintain the records specified under §62.14460 for 

a period of at least 5 years.

§ 62.14462 Where must I keep the records?

You must maintain all records specified under §62.14460 

onsite in either paper copy or computer-readable format, unless 

an alternative format is approved by the EPA Administrator.

§ 62.14463 What reporting requirements must I satisfy?

(a) You must report the following to the EPA Administrator 

(or delegated enforcement authority):

(1) The initial performance test data as recorded under 

§62.14451(a);

(2) The values for the site-specific operating parameters 

established pursuant to §62.14453, 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 §62.14431;

(4) If you use a bag leak detection system, analysis and 

supporting documentation demonstrating conformance with the EPA 

guidance and specifications for bag leak detection systems in 

§62.14454(e);
Page 45 of 73

(5) 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 §62.14453, as applicable;

(6) The highest maximum operating parameter and the lowest 

minimum operating parameter, as applicable, for each operating 

parameter recorded pursuant to §62.14453 for the calendar year 

preceding the year being reported, in order to provide a summary 

of the performance of the HMIWI over a 2-year period;

(7) Any information recorded under §62.14460(c) through (e) 

for the calendar year being reported;

(8) Any information recorded under §62.14460(c) through (e) 

for the calendar year preceding the year being reported, in 

order to provide a summary of the performance of the HMIWI over 

a 2-year period;

(9) The results of any performance test conducted during 

the reporting period;

(10) If no exceedances or malfunctions occurred during the 

calendar year being reported, a statement that no exceedances 

occurred during the reporting period;

(11) Any use of the bypass stack, duration of such use, 

reason for malfunction and corrective action taken;
Page 46 of 73

(12) Records of the annual equipment inspections, any 

required maintenance and any repairs not completed within 10 

days of an inspection or the time frame established by the EPA 

Administrator (or delegated enforcement authority);

(13) 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 time frame 

established by the EPA Administrator (or delegated enforcement 

authority); 

(14) Concentrations of CO, PM, HCl, Pb, Cd, Hg, and 

dioxin/furan, as applicable, as determined by the CEMS or 

continuous automated sampling system, as applicable; and

(15) Petition for site-specific operating parameters under 

§62.14453(b).

(b) If you choose to submit an electronic copy of stack 

test reports to the EPA's WebFIRE database, as of December 31, 

2011, you must enter the test data into the EPA's database using 

the Electronic Reporting Tool (ERT) located at 

http://www.epa.gov/ttn/chief/ert/ert_tool.html.

§ 62.14464 When must I submit reports?

(a) You must submit the information specified in 

§§62.14463(a)(1) through (4) no later than 60 days following the 

initial performance test.
Page 47 of 73

(b) You must submit an annual report to the EPA 

Administrator (or delegated enforcement authority) no more than 

1 year following the submission of the information in paragraph 

(a) of this section and you must submit subsequent reports no 

more than 1 year following the previous report (once the unit is 

subject to permitting requirements under title V of the CAA, you

must submit these reports semiannually). The annual report must 

include the information specified in §§62.14463(a)(5) through 

(14), as applicable.

(c) You must submit semiannual reports containing any 

information recorded under §62.14460(c) through (e) no later 

than 60 days following the end of the semiannual reporting 

period. The first semiannual reporting period ends 6 months 

following the submission of information in paragraph (a) of this 

section. Subsequent reports must be submitted no later than 6 

calendar months following the previous report.

(d) You must submit your petition for site-specific 

operating parameters specified in §62.14463(a)(15) prior to your 

initial performance test. You may not conduct the initial 

performance test until the EPA Administrator has approved the 

petition.

§ 62.14465 Who must sign all submitted reports?
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All reports must be signed by the facilities manager 

(defined in §62.14490).

Compliance Schedule

§ 62.14470 When must I comply with this subpart if I plan to 

continue operation of my HMIWI?

If you plan to continue operation of your HMIWI, then you 

must follow the requirements in paragraph (a) or (b) of this 

section depending on when you plan to come into compliance with 

the requirements of this subpart.

(a) If you plan to continue operation and come into 

compliance with the requirements of this subpart by [date 1 year 

after publication of final rule], then you must complete the 

requirements of paragraphs (a)(1) through (a)(4) of this 

section.

(1) You must comply with the operator training and 

qualification requirements and inspection requirements (if 

applicable) of this subpart by [date 1 year after publication of 

final rule].

(2) You must achieve final compliance by [date 1 year after 

publication of final rule]. This includes incorporating all 

process changes and/or completing retrofit construction, 

connecting the air pollution control equipment or process 

changes such that the HMIWI is brought online, and ensuring that 
Page 49 of 73

all necessary process changes and air pollution control 

equipment are operating properly.

(3) You must conduct the initial performance test required 

by §62.14451(a) within 180 days after the date when you are 

required to achieve final compliance under paragraph (a)(2) of 

this section.

(4) You must submit an initial report including the results 

of the initial performance test and the waste management plan no 

later than 60 days following the initial performance test (see 

§§62.14463 and 62.14464 for complete reporting and recordkeeping 

requirements).

(b) If you plan to continue operation and come into 

compliance with the requirements of this subpart after [date 1 

year after publication of final rule], but before October 6, 

2014, then you must complete the requirements of paragraphs 

(b)(1) through (b)(4) of this section.

(1) You must comply with the operator training and 

qualification requirements and inspection requirements (if 

applicable) of this subpart by [date 1 year after publication of 

final rule].

(2) You must demonstrate that you are taking steps towards 

compliance with the emission limits in the subpart by completing 

the increments of progress in paragraphs (b)(2)(i) through 
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(b)(2)(v) of this section. You must submit notification to the 

EPA Administrator (or delegated enforcement authority) within 10 

business days of completing (or failing to complete by the 

applicable date) each of the increments of progress listed in 

paragraphs (b)(2)(i) through (b)(2)(v) of this section. Your 

notification must be signed by your facilities manager (defined 

in §62.14490).

(i) You must submit a final control plan by [INSERT DATE 3 

MONTHS FROM DATE OF PUBLICATION OF THE FEDERAL REGISTER]. Your 

final control plan must, at a minimum, include a description of 

the air pollution control device(s) or process changes that will 

be employed for each unit to comply with the emissions limits 

and other requirements of this subpart.

(ii) You must award contract(s) for on-site construction, 

onsite installation of emissions control equipment or 

incorporation of process changes by [INSERT DATE 7 MONTHS FROM 

DATE OF PUBLICATION OF THE FEDERAL REGISTER]. You must submit a 

signed copy of the contract(s) awarded.

(iii) You must begin on-site construction, begin onsite 

installation of emissions control equipment or begin process 

changes needed to meet the emissions limits as outlined in the 

final control plan by January 6, 2014.
Page 51 of 73

(iv) You must complete onsite construction, installation of 

emissions control equipment, or process changes by August 6, 

2014.

(v) You must achieve final compliance by October 6, 2014.

This includes incorporating all process changes and/or 

completing retrofit construction as described in the final 

control plan, connecting the air pollution control equipment or 

process changes such that the HMIWI is brought on line, and 

ensuring that all necessary process changes and air pollution 

control equipment are operating properly.

(3) You must conduct the initial performance test required 

by §62.14451(a) within 180 days after the date when you are 

required to achieve final compliance under paragraph (b)(2)(v) 

of this section.

(4) You must submit an initial report including the result 

of the initial performance test and the waste management plan no 

later than 60 days following the initial performance test (see 

§§62.14463 and 62.14464 for complete reporting and recordkeeping 

requirements).

§ 62.14471 When must I comply with this subpart if I plan to 

shut down?
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If you plan to shut-down, then you must follow the 

requirements in either paragraph (a) or (b) of this section 

depending on when you plan to shut down.

(a) If you plan to shut down by [date 1 year after 

publication of final rule], rather than come into compliance 

with the requirements of this subpart then you must shut-down by 

[date 1 year after publication of final rule], to avoid coverage 

under any of the requirements of this subpart.

(b) If you plan to shut down rather than come into 

compliance with the requirements of this subpart, but are unable 

to shut down by [date 1 year after publication of final rule],

then you may petition the EPA for an extension by following the 

procedures outlined in paragraphs (b)(1) through (b)(3) of this 

section.

(1) You must submit your request for an extension to the 

EPA Administrator (or delegated enforcement authority) by [date 

90 days after publication of final rule]. Your request must 

include:

(i) Documentation of the analyses undertaken to support 

your need for an extension, including an explanation of why your 

requested extension date is sufficient time for you to shut-down 

while [date 1 year after publication of final rule], does not 

provide sufficient time for shut-down. Your documentation must 
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include an evaluation of the option to transport your waste 

offsite to a commercial medical waste treatment and disposal 

facility on a temporary or permanent basis; and

(ii) Documentation of incremental steps of progress, 

including dates for completing the increments of progress, that 

you will take towards shutting down. Some suggested incremental 

steps of progress towards shut down are provided as follows:

If you . . .

Then your increments of progress 

could be . . .

Need an extension so you can install an onsite 

alternative waste treatment technology before you 

shut down your HMIWI,

Date when you will enter into a 

contract with an alternative 

treatment technology vendor,

Date for initiating onsite 

construction or installation of 

the alternative technology, and

Date for completing onsite 

construction or installation of 

the alternative technology, and

Date for shutting down the HMIWI.

Need an extension so you can acquire the services 

of a commercial medical/infectious waste disposal 

company before you shut down your HMIWI,

Date when price quotes will be 

obtained from commercial disposal 

companies,

Date when you will enter into a 

contract with a commercial 

disposal company, and

Date for shutting down the HMIWI.

(2) You must shut-down no later than October 6, 2014.

(3) You must comply with the operator training and 

qualification requirements and inspection requirements (if 

applicable) of this subpart by [date 1 year after publication of 

final rule].

§ 62.14472 When must I comply with this subpart if I plan to 

shut down and later restart?
Page 54 of 73

If you wish to shut down and later restart, then you must 

follow the compliance times in paragraph (a), (b), or (c) of 

this section depending on when you shut down and restart.

(a) If you plan to shutdown and restart prior to October 6, 

2014, then you must:

(1) Meet the compliance schedule outlined in §63.14470(a) 

if you restart prior to [date 1 year after publication of final 

rule]; or

(2) Meet the compliance schedule outlined in §62.14470(b) 

if you restart after [date 1 year after publication of final 

rule]. Any missed increments of progress need to be completed 

prior to or upon the date of restart.

(b) If you plan to shutdown by [date 1 year after 

publication of final rule], and restart after October 6, 2014, 

then you must complete the requirements of paragraphs (b)(1) 

through (b)(5) of this section.

(1) You must shut-down by [date 1 year after publication of 

final rule].

(2) You must comply with the operator training and 

qualification requirements and inspection requirements (if 

applicable) of this subpart before restarting your HMIWI.

(3) You must achieve final compliance upon restarting your 

HMIWI. This includes incorporating all process changes and/or 
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completing retrofit construction, connecting the air pollution 

control equipment or process changes such that the HMIWI is 

brought on line, and ensuring that all necessary process changes 

and air pollution control equipment are operating properly.

(4) You must conduct the initial performance test required 

by §62.14451(a) within 180 days after the date when you restart.

(5) You must submit an initial report including the results 

of the initial performance test and the waste management plan no 

later than 60 days following the initial performance test (see 

§§62.14463 and 62.14464 for complete reporting and recordkeeping 

requirements).

(c) If you plan to shutdown after [date 1 year after 

publication of final rule], and restart after October 6, 2014, 

then you must complete the requirements of paragraphs (c)(1) and 

(c)(2) of this section.

(1) You must petition the EPA for an extension by following 

the procedures outlined in §63.14471(b)(1) through (b)(3).

(2) You must comply with the requirements of paragraphs 

(b)(2) through (b)(5) of this section.

Permitting Obligation

§ 62.14480 Does this subpart require me to obtain an operating 

permit under title V of the Clean Air Act and implementing 

regulations?
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This subpart requires you to obtain an operating permit 

under title V of the Clean Air Act and implementing regulations

(“title V permit”) unless you are only subject to the 

recordkeeping and reporting requirements listed at 

§62.14400(b)(1) or (b)(2), and §62.14400(c), of this subpart. 

Also, if you own or operate a unit described in 

§§62.14400(b)(3), (b)(4), (b)(5) or (b)(6), you are not subject 

to any requirements of this subpart; therefore, this subpart 

does not require you to obtain a title V permit.

§ 62.14481 When must I submit a title V permit application for 

my HMIWI?

You must submit a title V permit application in time for it 

to be determined or deemed complete by no later than September 

15, 2000 or by the effective date of a title V permits program 

in the jurisdiction in which the unit is located, whichever is 

later. (An earlier deadline may apply if your HMIWI is also 

subject to title V permitting requirements because of some other 

triggering requirement.) A “complete” title V permit application 

is one that has been approved by the appropriate permitting 

authority as complete under Section 503 of the Clean Air Act and 

40 CFR parts 70 and 71. It is not enough to have submitted a 

title V permit application by September 15, 2000 because the 

application must be determined or deemed complete by the 
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permitting authority by that date for your HMIWI to operate 

after that date in compliance with Federal law.

Definitions

§ 62.14490 Definitions.

Bag leak detection system means an instrument that is 

capable of monitoring PM loadings in the exhaust of a FF in 

order to detect bag failures. A bag leak detection system 

includes, but is not limited to, an instrument that operates on 

triboelectric, light-scattering, light-transmittance or other 

effects to monitor relative PM loadings.

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.

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, 
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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.
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Continuous emission monitoring system or CEMS means a 

monitoring system for continuously measuring and recording the 

emissions of a pollutant.

Continuous HMIWI means an HMIWI that is designed to allow 

waste charging and ash removal during combustion.

Dioxins/furans means the combined emissions of tetrathrough octa-chlorinated dibenzo-para-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.
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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.

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, 
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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 paragraph (2) of this definition;

(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 
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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 must operate within 

established parameters as much as possible, and monitoring of 

all applicable operating parameters must 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.
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Maximum design waste burning capacity means:

(1) For intermittent and continuous HMIWI,

C = Pv x 15,000/8,500 (Eq. 2)

Where:

C = HMIWI capacity, lb/hr

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 x 4.5/8 (Eq. 3)

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 
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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.
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(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 include in this 

category.

(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 
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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) of this definition;

(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
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(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 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 
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during the most recent performance test demonstrating compliance 

with the applicable emission limits.

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 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 SNCR

technology (taken, at a minimum, once 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.
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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 or NOX emissions limits.

Modification or Modified HMIWI means any change to an HMIWI 

unit after April 6, 2010, 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 
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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 must commence no less than 2 hours after the last 

charge to the incinerator. For intermittent HMIWI, shutdown 
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must commence no less than 4 hours after the last charge to the 

incinerator. For batch HMIWI, shutdown must commence no less 

than 5 hours after the high-air phase of combustion has been 

completed.

Small HMIWI means:

(1) Except as provided in paragraph (2) of this definition;

(i) An HMIWI whose maximum design waste burning capacity is 

less than or equal to 200 pounds per hour; or

(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.

Small rural HMIWI means a small HMIWI which is located more 

than 50 miles from the boundary of the nearest Standard 

Metropolitan Statistical Area and which burns less than 2,000 

pounds per week of hospital waste and medical/ infectious waste.

Standard conditions means a temperature of 20 °C and a 

pressure of 101.3 kilopascals.
Page 72 of 73

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. This information can also be obtained from the nearest 

Metropolitan Planning Organization.

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.

Delegation of Authority

§ 62.14495 What authorities will be retained by the EPA 

Administrator?

The following authorities will be retained by the EPA 

Administrator and not transferred to the State or Tribe:

(a) The requirements of §62.14453(b) establishing operating 

parameters when using controls other than a dry scrubber 

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

followed by a fabric filter and a wet scrubber.
Page 73 of 73

(b) Approval of alternative methods of demonstrating 

compliance under 40 CFR 60.8, including:

(1) Approval of CEMS for PM, HCl, multi-metals and Hg where 

used for purposes of demonstrating compliance,

(2) Approval of continuous automated sampling systems for 

dioxin/furan and Hg where used for purposes of demonstrating 

compliance, and

(3) Approval of major alternatives to test methods;

(c) Approval of major alternatives to monitoring;

(d) Waiver of recordkeeping requirements; and

(e) Performance test and data reduction waivers under 40 

CFR 60.8(b).

Table 1 to Subpart HHH of Part 62—Emissions Limits for Small 

Rural, Small, Medium, and Large HMIWI

For the 

air 

pollutant

You must meet this

emissions limit

With these units

(7 percent oxygen, 

dry basis)

Using this 

averaging 

timea

And determining 

compliance using 

this methodb

HMIWI size

Small 

rural Small Medium Large

Particula

te matter

87 

(0.038

)

66 

(0.02

9)

46 

(0.020)

c

34 

(0.015)

d

25 

(0.011)

Milligrams per dry 

standard cubic 

meter (grains per 

dry standard cubic 

foot)

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

20 20 5.5 11 Parts per million 

by volume

3-run 

average (1-

hour minimum 

sample time 

per run)

EPA Reference 

Method 10 or 10B 

of appendix A-4 

of part 60

Dioxins/f

urans

240 

(100) 

16 

(7.0) 

0.85 

(0.37) 

9.3 

(4.1) 

Nanograms per dry 

standard cubic 

3-run 

average (4-

EPA Reference 

Method 23 of 
Page 74 of 73

For the 

air 

pollutant

You must meet this

emissions limit

With these units

(7 percent oxygen, 

dry basis)

Using this 

averaging 

timea

And determining 

compliance using 

this methodb

HMIWI size

Small 

rural Small Medium Large

or

5.1 

(2.2)

or

0.013 

(0.00

57)

or

0.020 

(0.0087

)

or

0.054 

(0.024)

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)

hour minimum 

sample time 

per run)

appendix A-7 of 

part 60

Hydrogen 

chloride

810 44c

15d

7.7 6.6 Parts per million 

by volume

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

55 4.2 4.2 9.0 Parts per million 

by volume

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

130 190 190 140 Parts per million 

by volume

3-run 

average (1-

hour minimum 

sample time 

per run)

EPA Reference 

Method 7 or 7E of 

appendix A-4 of 

part 60

Lead 0.50 

(0.22)

0.31 

(0.14

)

0.018 

(0.0079

)

0.036 

(0.016)

Milligrams per dry 

standard cubic 

meter (grains per 

thousand dry 

standard cubic 

feet)

3-run 

average (1-

hour minimum 

sample time 

per run)

EPA Reference 

Method 29 of 

appendix A-8 of 

part 60

Cadmium 0.11 

(0.048

)

0.017 

(0.00

74)

0.013 

(0.0057

)

0.0092 

(0.0040

)

Milligrams per dry 

standard cubic 

meter (grains per 

thousand dry 

standard cubic 

feet)

3-run 

average (1-

hour minimum 

sample time 

per run)

EPA Reference 

Method 29 of 

appendix A-8 of 

part 60

Mercury 0.051 

(0.002

2)

0.014 

(0.00

61)

0.025 

(0.011)

0.018 

(0.0079

)

Milligrams per dry 

standard cubic 

meter (grains per 

thousand dry 

standard cubic 

feet)

3-run 

average (1-

hour minimum 

sample time 

per run)

EPA Reference 

Method 29 of 

appendix A-8 of 

part 60

a

Except as allowed under §§62.14452(o)-(q) for HMIWI equipped with CEMS or continuous 

automated sampling systems.

b

Does not include CEMS, continuous automated sampling systems, and approved 

alternative non-EPA test methods allowed under §62.14452(d) and (m).
Page 75 of 73

c Limits for those HMIWI for which construction or modification was commenced 

according to §62.14400(a)(2)(i).

d Limits for those HMIWI for which construction or modification was commenced 

according to §62.14400(a)(2)(ii).

Table 2 to Subpart HHH of Part 62—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 1

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 0.0003

2,3,7,8-tetrachlorinated dibenzofuran 0.1

2,3,4,7,8-pentachlorinated dibenzofuran 0.3

1,2,3,7,8-pentachlorinated dibenzofuran 0.03

1,2,3,4,7,8-hexachlorinated dibenzofuran 0.1

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 0.0003

Table 3 to Subpart HHH of Part 62—Operating Parameters To Be 

Monitored and Minimum Measurement and Recording Frequencies

Operating 

parameters to be 

monitored

Minimum frequency HMIWI

Data 

measurement

Data 

recording

HMIWI with 

combustion 

control 

only

HMIWI

with dry 

scrubber 

followed 

by FF

HMIWI

with wet 

scrubber

HMIWI with

dry 

scrubber 

followed 

by FF and 

wet 

scrubber

HMIWI 

with 

SNCR 

system

Maximum operating 

parameters:

Maximum charge 

rate

Once per 

charge

Once per 

charge

    

Maximum FF inlet 

temperature

Continuous Once per 

minute

 

Maximum flue gas 

temperature

Continuous Once per 

minute

 

Minimum operating 

parameters:
Page 76 of 73

Operating 

parameters to be 

monitored

Minimum frequency HMIWI

Data 

measurement

Data 

recording

HMIWI with 

combustion 

control 

only

HMIWI

with dry 

scrubber 

followed 

by FF

HMIWI

with wet 

scrubber

HMIWI with

dry 

scrubber 

followed 

by FF and 

wet 

scrubber

HMIWI 

with 

SNCR 

system

Minimum secondary 

chamber 

temperature

Continuous Once per 

minute

    

Minimum 

dioxin/furan 

sorbent flow rate

Hourly Once per 

hour

 

Minimum HCl 

sorbent flow rate

Hourly Once per 

hour

 

Minimum mercury 

(Hg) sorbent flow 

rate

Hourly Once per 

hour

 

Minimum pressure 

drop across the 

wet scrubber or 

minimum 

horsepower or 

amperage to wet 

scrubber

Continuous Once per 

minute

 

Minimum scrubber 

liquor flow rate

Continuous Once per 

minute

 

Minimum scrubber 

liquor pH

Continuous Once per 

minute

 

Minimum reagent 

flow rate

Hourly Once per 

hour

