§ 284.321. Infectious waste monitoring requirements.

 (a)  A person or municipality that disinfects infectious waste shall monitor the waste to ensure the following:

   (1)  For thermal processing or incineration, the absence of anaerobic or aerobic bacterial growth in a composite sample of processing residue or ash.

   (2)  For other disinfection processes, both of the following are met:

     (i)   The process shall be capable of inactivating vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites and mycobacteria at a 6 log 10 reduction or greater.

     (ii)   The process shall be capable of inactivating B. stearothermophilus spores, B. pumilus or B. subtilis spores at a 4 log 10 reduction or greater.

 (b)  The operator of a facility that incinerates or thermally processes infectious waste shall submit to the Department a microbiological analysis of a composite sample of the processing or ash residue on forms provided by the Department at a minimum, quarterly during the life of the facility.

 (c)  The operator of a facility that incinerates infectious waste shall submit to the Department, at least annually during the life of the facility, a chemical analysis of composite samples of the ash residue on forms provided by the Department.

 (d)  If the facility disinfects infectious waste by means other than incineration or thermal processing, the operator shall perform a microbiological analysis of indicators removed from the processed waste. The analysis shall be conducted at a minimum, every 40 hours during the operational life of the facility, unless otherwise provided in a permit. The analyses shall be made available to the Department upon request.

 (e)  Unless the Department approves another indicator or test in writing, the following indicators shall be used to establish and verify the following processes:

   (1)  For autoclaving, spores of Bacillus stearothermophilus.

   (2)  For dry heat, gas or chemical disinfection, spores of Bacillus subtilis variety niger (globigii). Ethylene oxide may not be used for gas disinfection.

   (3)  For ionizing radiation, spores of Bacillus pumilus.

 (f)  Indicators used for methods of disinfection other than incineration or thermal processing shall be located prior to disinfection at a point where disinfection will be most difficult to achieve.

 (g)  Infectious waste will be considered to be infectious after disinfection, unless one of the following has occurred:

   (1)  For disinfection processes other than incineration or thermal processing, the indicator spores are determined by microbiological analysis to have been destroyed in accordance with subsection (a).

   (2)  For incineration or thermal processing using a test other than an indicator spore, a microbiological analysis determines that disinfection has occurred in accordance with subsection (a).

 (h)  The operator of the disinfection facility shall so certify that the requirements of subsection (a) have been met on a form provided by the Department.

 (i)  Ash or other processing residue shall be stored in accordance with §  284.418 or §  284.419 (relating to storage and containment of ash residue from infectious or chemotherapeutic waste incineration; and storage and containment of processing residue from an infectious or chemotherapeutic waste facility).

 (j)  Ash or other processing residue shall be transported in accordance with §  284.511 or §  284.514 (relating to transportation of ash residue from infectious or chemotherapeutic waste incineration; and transportation of processing residue from an infectious or chemotherapeutic waste facility).

 (k)  Compactors, grinders or similar devices may not be used to reduce the volume of infectious waste before the waste has been rendered noninfectious. If the volume reduction device is within a continuous, enclosed disinfection process and part of one processing system, then the reduction device may be used.

 (l)  The operator of an infectious waste processing facility shall dispose of ash or other processing residue from the facility in a landfill that has been approved by the Department to accept the waste, if the waste is disposed in this Commonwealth.

 (m)  In addition to other applicable requirements, an autoclave facility shall comply with the following:

   (1)  The processing of pathological waste is prohibited.

   (2)  The facility shall maintain a retention time for processing bulk fluids (greater than 500 ml) which allows for the complete vaporization of fluids.

   This section cited in 25 Pa. Code §  271.1 (relating to definitions); 25 Pa. Code §  273.511 (relating to processed infectious waste disposal); 25 Pa. Code §  284.2 (relating to permit-by-rule for infectious or chemotherapeutic waste processing facilities; qualifying facilities; general requirements); 25 Pa. Code §  284.111 (relating to application for general permit); and 25 Pa. Code §  284.311 (relating to plan for monitoring).