[Title 40 CFR 60.51c]
[Code of Federal Regulations (annual edition) - July 1, 2009 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)]
[Subchapter C - AIR PROGRAMS (CONTINUED)]
[Part 60 - STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES--]
[Subpart Ec - Standards of Performance for Hospital/Medical/Infectious]
[Sec. 60.51c - Definitions.]
[From the U.S. Government Printing Office]


40PROTECTION OF ENVIRONMENT62009-07-012009-07-01false60.51cSec. 60.51cPROTECTION OF ENVIRONMENTENVIRONMENTAL PROTECTION AGENCY (CONTINUED)AIR PROGRAMS (CONTINUED)STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES--Standards of Performance for Hospital/Medical/Infectious
Sec. 60.51c  Definitions.

    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, 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.
    Continuous emission monitoring system or CEMS means a monitoring 
system for continuously measuring and recording the emissions of a 
pollutant from an affected facility.
    Continuous HMIWI means an HMIWI that is designed to allow waste 
charging and ash removal during combustion.
    Dioxins/furans means the combined emissions of tetra-through octa-
chlorinated 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.
    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

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not include human corpses, remains, and anatomical parts that are 
intended for interment or cremation.
    Infectious agent means any organism (such as a virus or bacteria) 
that is capable of being communicated by invasion and multiplication in 
body tissues and capable of causing disease or adverse health impacts in 
humans.
    Intermittent HMIWI means an HMIWI that is designed to allow waste 
charging, but not ash removal, during combustion.
    Large HMIWI means:
    (1) Except as provided in (2);
    (i) An HMIWI whose maximum design waste burning capacity is more 
than 500 pounds per hour; or
    (ii) A continuous or intermittent HMIWI whose maximum charge rate is 
more than 500 pounds per hour; or
    (iii) A batch HMIWI whose maximum charge rate is more than 4,000 
pounds per day.
    (2) The following are not large HMIWI:
    (i) A continuous or intermittent HMIWI whose maximum charge rate is 
less than or equal to 500 pounds per hour; or
    (ii) A batch HMIWI whose maximum charge rate is less than or equal 
to 4,000 pounds per day.
    Low-level radioactive waste means waste material which contains 
radioactive nuclides emitting primarily beta or gamma radiation, or 
both, in concentrations or quantities that exceed applicable federal or 
State standards for unrestricted release. Low-level radioactive waste is 
not high-level radioactive waste, spent nuclear fuel, or by-product 
material as defined by the Atomic Energy Act of 1954 (42 U.S.C. 
2014(e)(2)).
    Malfunction means any sudden, infrequent, and not reasonably 
preventable failure of air pollution control equipment, process 
equipment, or a process to operate in a normal or usual manner. Failures 
that are caused, in part, by poor maintenance or careless operation are 
not malfunctions. During periods of malfunction the operator shall 
operate within established parameters as much as possible, and 
monitoring of all applicable operating parameters shall continue until 
all waste has been combusted or until the malfunction ceases, whichever 
comes first.
    Maximum charge rate means:
    (1) For continuous and intermittent HMIWI, 110 percent of the lowest 
3-hour average charge rate measured during the most recent performance 
test demonstrating compliance with all applicable emission limits.
    (2) For batch HMIWI, 110 percent of the lowest daily charge rate 
measured during the most recent performance test demonstrating 
compliance with all applicable emission limits.
    Maximum design waste burning capacity means:
    (1) For intermittent and continuous HMIWI,

C=PV x 15,000/8,500

Where:

C=HMIWI capacity, lb/hr
PV=primary chamber volume, ft\3\
15,000=primary chamber heat release rate factor, Btu/ft\3\/hr
8,500=standard waste heating value, Btu/lb;

    (2) For batch HMIWI,

C=PV x 4.5/8

Where:

C=HMIWI capacity, lb/hr
PV=primary chamber volume, ft\3\
4.5=waste density, lb/ft\3\
8=typical hours of operation of a batch HMIWI, hours.

    Maximum fabric filter inlet temperature means 110 percent of the 
lowest 3-hour average temperature at the inlet to the fabric filter 
(taken, at a minimum, once every minute) measured during the most recent 
performance test demonstrating compliance with the dioxin/furan emission 
limit.
    Maximum flue gas temperature means 110 percent of the lowest 3-hour 
average temperature at the outlet from the wet scrubber (taken, at a 
minimum, once every minute) measured during the most recent performance 
test demonstrating compliance with the mercury (Hg) emission limit.
    Medical/infectious waste means any waste generated in the diagnosis, 
treatment, or immunization of human beings or animals, in research 
pertaining thereto, or in the production or testing of biologicals that 
is listed in

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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 Sec. 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 mation; and domestic sewage materials 
identified in Sec. 261.4(a)(1) of this chapter.
    (1) Cultures and stocks of infectious agents and associated 
biologicals, including: cultures from medical and pathological 
laboratories; cultures and stocks of infectious agents from research and 
industrial laboratories; wastes from the production of biologicals; 
discarded live and attenuated vaccines; and culture dishes and devices 
used to transfer, inoculate, and mix cultures.
    (2) Human pathological waste, including tissues, organs, and body 
parts and body fluids that are removed during surgery or autopsy, or 
other medical procedures, and specimens of body fluids and their 
containers.
    (3) Human blood and blood products including:
    (i) Liquid waste human blood;
    (ii) Products of blood;
    (iii) Items saturated and/or dripping with human blood; or
    (iv) Items that were saturated and/or dripping with human blood that 
are now caked with dried human blood; including serum, plasma, and other 
blood components, and their containers, which were used or intended for 
use in either patient care, testing and laboratory analysis or the 
development of pharmaceuticals. Intravenous bags are also 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 contact with infectious agents, such as used slides and 
cover slips.
    (5) Animal waste including contaminated animal carcasses, body 
parts, and bedding of animals that were known to have been exposed to 
infectious agents during research (including research in veterinary 
hospitals), production of biologicals or testing of pharmaceuticals.
    (6) Isolation wastes including biological waste and discarded 
materials contaminated with blood, excretions, exudates, or secretions 
from humans who are isolated to protect others from certain highly 
communicable diseases, or isolated animals known to be infected with 
highly communicable diseases.
    (7) Unused sharps including the following unused, discarded sharps: 
hypodermic needles, suture needles, syringes, and scalpel blades.
    Medium HMIWI means:
    (1) Except as provided in paragraph (2);
    (i) An HMIWI whose maximum design waste burning capacity is more 
than 200 pounds per hour but less than or equal to 500 pounds per hour; 
or
    (ii) A continuous or intermittent HMIWI whose maximum charge rate is 
more than 200 pounds per hour but less than or equal to 500 pounds per 
hour; or
    (iii) A batch HMIWI whose maximum charge rate is more than 1,600 
pounds per day but less than or equal to 4,000 pounds per day.
    (2) The following are not medium HMIWI:
    (i) A continuous or intermittent HMIWI whose maximum charge rate is 
less than or equal to 200 pounds per hour or more than 500 pounds per 
hour; or
    (ii) A batch HMIWI whose maximum charge rate is more than 4,000 
pounds per day or less than or equal to 1,600 pounds per day.
    Minimum dioxin/furan sorbent flow rate means 90 percent of the 
highest 3-hour average dioxin/furan sorbent flow rate (taken, at a 
minimum, once every hour) measured during the most recent performance 
test demonstrating compliance with the dioxin/furan emission limit.

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    Minimum Hg sorbent flow rate means 90 percent of the highest 3-hour 
average Hg sorbent flow rate (taken, at a minimum, once every hour) 
measured during the most recent performance test demonstrating 
compliance with the Hg emission limit.
    Minimum hydrogen chloride (HCl) sorbent flow rate means 90 percent 
of the highest 3-hour average HCl sorbent flow rate (taken, at a 
minimum, once every hour) measured during the most recent performance 
test demonstrating compliance with the HCl emission limit.
    Minimum horsepower or amperage means 90 percent of the highest 3-
hour average horsepower or amperage to the wet scrubber (taken, at a 
minimum, once every minute) measured during the most recent performance 
test demonstrating compliance with the applicable emission limits.
    Minimum pressure drop across the wet scrubber means 90 percent of 
the highest 3-hour average pressure drop across the wet scrubber PM 
control device (taken, at a minimum, once every minute) measured during 
the most recent performance test demonstrating compliance with the PM 
emission limit.
    Minimum scrubber liquor flow rate means 90 percent of the highest 3-
hour average liquor flow rate at the inlet to the wet scrubber (taken, 
at a minimum, once every minute) measured during the most recent 
performance test demonstrating compliance with all applicable emission 
limits.
    Minimum scrubber liquor pH means 90 percent of the highest 3-hour 
average liquor pH at the inlet to the wet scrubber (taken, at a minimum, 
once every minute) measured during the most recent performance test 
demonstrating compliance with the HCl emission limit.
    Minimum secondary chamber temperature means 90 percent of the 
highest 3-hour average secondary chamber temperature (taken, at a 
minimum, once every minute) measured during the most recent performance 
test demonstrating compliance with the PM, CO, or dioxin/furan emission 
limits.
    Modification or Modified HMIWI means any change to an HMIWI unit 
after the effective date of these standards such that:
    (1) The cumulative costs of the modifications, over the life of the 
unit, exceed 50 per centum of the original cost of the construction and 
installation of the unit (not including the cost of any land purchased 
in connection with such construction or installation) updated to current 
costs, or
    (2) The change involves a physical change in or change in the method 
of operation of the unit which increases the amount of any air pollutant 
emitted by the unit for which standards have been established under 
section 129 or section 111.
    Operating day means a 24-hour period between 12:00 midnight and the 
following midnight during which any amount of hospital waste or medical/
infectious waste is combusted at any time in the HMIWI.
    Operation means the period during which waste is combusted in the 
incinerator excluding periods of startup or shutdown.
    Particulate matter or PM means the total particulate matter emitted 
from an HMIWI as measured by EPA Reference Method 5 or EPA Reference 
Method 29.
    Pathological waste means waste material consisting of only human or 
animal remains, anatomical parts, and/or tissue, the bags/containers 
used to collect and transport the waste material, and animal bedding (if 
applicable).
    Primary chamber means the chamber in an HMIWI that receives waste 
material, in which the waste is ignited, and from which ash is removed.
    Pyrolysis means the endothermic gasification of hospital waste and/
or medical/infectious waste using external energy.
    Secondary chamber means a component of the HMIWI that receives 
combustion gases from the primary chamber and in which the combustion 
process is completed.
    Shutdown means the period of time after all waste has been combusted 
in the primary chamber. For continuous HMIWI, shutdown shall commence no 
less than 2 hours after the last charge to the incinerator. For 
intermittent HMIWI, shutdown shall commence no less than 4 hours after 
the last charge

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to the incinerator. For batch HMIWI, shutdown shall commence no less 
than 5 hours after the high-air phase of combustion has been completed.
    Small HMIWI means:
    (1) Except as provided in (2);
    (i) An HMIWI whose maximum design waste burning capacity is less 
than or equal to 200 pounds per hour; or
    (ii) A continuous or intermittent HMIWI whose maximum charge rate is 
less than or equal to 200 pounds per hour; or
    (iii) A batch HMIWI whose maximum charge rate is less than or equal 
to 1,600 pounds per day.
    (2) The following are not small HMIWI:
    (i) A continuous or intermittent HMIWI whose maximum charge rate is 
more than 200 pounds per hour;
    (ii) A batch HMIWI whose maximum charge rate is more than 1,600 
pounds per day.
    Standard conditions means a temperature of 20 [deg]C and a pressure 
of 101.3 kilopascals.
    Startup means the period of time between the activation of the 
system and the first charge to the unit. For batch HMIWI, startup means 
the period of time between activation of the system and ignition of the 
waste.
    Wet scrubber means an add-on air pollution control device that 
utilizes an alkaline scrubbing liquor to collect particulate matter 
(including nonvaporous metals and condensed organics) and/or to absorb 
and neutralize acid gases.