that will be employed for each unit to comply with the emission limits and other requirements of this subpart.

(ii) You must award contract(s) for onsite construction, onsite installation of emission control equipment, or incorporation of process changes by April 15, 2001. You must submit a signed copy of the contract(s) awarded.

(iii) You must begin onsite construction, begin onsite installation of emission control equipment, or begin process changes needed to meet the emission limits as outlined in the final control plan by December 15, 2001.

(iv) You must complete onsite construction, installation of emission control equipment, or process changes by July 15, 2002.

(v) You must achieve final compliance by September 15, 2002. 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 §62.14450(a) (for small rural HMIWI) or §62.14451(a) (for HMIWI that are not small rural HMIWI) 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? 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 August 15, 2001, rather that come into compliance with the requirements of this subpart, then you must shut down by August 15, 2001, 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 August 15, 2001, then you may petition 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 November 13, 2000. 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 August 15, 2001, does not provide sufficient time for shut down. Your documentation must 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:

§ 62.14472 When must I comply with this subpart if I plan to shut down and later restart?

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 shut down and restart prior to September 15, 2002, then you must:

(1) Meet the compliance schedule outlined in §63.14470(a) if you restart prior to August 15, 2001; or

(2) Meet the compliance schedule outlined in § 62.14470(b) if you restart after August 15, 2001. Any missed increments of progress need to be completed prior to or upon the date of restart.

(b) If you plan to shut down by August 15, 2001, and restart after September 15, 2002, then you must complete the requirements of paragraphs (b)(1) through (b)(5) of this section.

(1) You must shut down by August 15, 2001.

(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 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 § 62.14450(a) (for small rural HMIWI) or §62.14451(a) (for HMIWI that are not small rural

HMIWI) 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 shut down after August 15, 2001, and restart after September 15, 2002, then you must complete the requirements of paragraphs (c)(1) and (c)(2) of this section.

(1) You must petition EPA for an extension by following the procedures outlined in §63.14471 paragraphs (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?

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 permitting authority by that date for your HMIWI to operate after that date in compliance with Federal law.

DEFINITIONS

§ 62.14490 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 calcu

lating 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.

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 octachlorinated 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.

erator

Hospital/medical/infectious waste incinoperator or HMIWI operator means any person who operates, controls or supervises the day-to-day operation of an HMIWI.

Hospital waste means discards generated at a hospital, except unused items returned to the manufacturer. The definition of hospital waste does not include human corpses, remains, and anatomical parts that are intended for interment or cremation.

Infectious agent means any organism (such as a virus or bacteria) that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans.

Intermittent HMIWI means an HMIWI that is designed to allow waste charging, but not ash removal, during combustion.

Large HMIWI means:

(1) Except as provided in 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 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 byproduct 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 3hour 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,

Where:

C = HMIWI capacity, lb/hr

Pv = primary chamber volume, ft3

4.5

8

waste density, lb/ft33

typical hours of operation of a batch HMIWI, hours.

Maximum fabric filter inlet temperature means 110 percent of the lowest 3-hour average temperature at the inlet to the fabric filter (taken, at a minimum, once every minute) measured during the most recent performance test demonstrating compliance with the dioxin/ furan emission limit.

Maximum flue gas temperature means 110 percent of the lowest 3-hour average temperature at the outlet from the wet scrubber (taken, at a minimum, once every minute) measured during the most recent performance test demonstrating compliance with the mercury (Hg) emission limit.

Medical/infectious waste means any waste generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals that is listed in paragraphs (1) through (7) of this definition. The definition of medical/infectious waste does not include hazardous waste identified or listed under the regulations in part 261 of this chapter; household waste, as defined in § 261.4(b)(1) of this chapter; ash from incineration of medical/infectious waste, once the incineration process has been completed; human corpses, remains, and anatomical parts that are intended for interment or cremation; and domestic sewage materials identified § 261.4(a)(1) of this chapter.

in

(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 hypo

dermic 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 dis

eases.

(7) Unused sharps including the following unused, discarded sharps: hypodermic needles, suture needles, syringes, and scalpel blades.