§ 284.2. Permit-by-rule for infectious or chemotherapeutic waste processing facilities; qualifying facilities; general requirements.

 (a)  If the requirements of this section are met, the following onsite processing facilities for infectious and chemotherapeutic waste shall be deemed to have a municipal waste processing permit under this article:

   (1)  An onsite autoclave facility, including one which renders waste unrecognizable, which processes at least 50% of its own infectious waste generated onsite and accepts offsite waste for disinfection only from small quantity generators that generate less than 220 pounds per month of infectious waste if the following conditions are met:

     (i)   Processing of pathological waste is prohibited.

     (ii)   The retention time for processing bulk fluids (greater than 500 ml) allows for the complete vaporization of fluids.

   (2)  An onsite incineration facility that burns at least 50% of its own infectious or chemotherapeutic waste generated onsite and accepts offsite infectious or chemotherapeutic waste for incineration only from small quantity generators that generate less than 220 pounds per month of infectious or chemotherapeutic waste. This onsite incineration facility may process municipal waste generated onsite as long as the resulting ash is managed as processed infectious and chemotherapeutic waste.

   (3)  An onsite steam and superheated water disinfection facility which processes infectious waste, including one which renders waste unrecognizable, which processes at least 50% of its own infectious waste generated onsite and accepts offsite waste for disinfection only from small quantity generators that generate less than 220 pounds per month of infectious waste. Processing of pathological waste is prohibited.

 (b)  Generators that process and disinfect less than 220 pounds per month of infectious waste onsite and render the waste unrecognizable will be deemed to have municipal waste processing permits under this article if the requirements under subsections (c)—(g) are met. Generators that process and disinfect less than 220 pounds per month of infectious waste onsite without rendering the waste unrecognizable will be deemed to have municipal waste processing permits under this article if the requirements under subsections (c)—(g) are met and if the following requirements are met:

   (1)  The generator may dispose of the processed waste in a landfill or have the waste incinerated in a facility that has obtained written approval from the Department to accept the waste.

   (2)  The generator shall comply with the manifest requirements in §  284.701(b)(5) (relating to scope).

 (c)  The following requirements shall be met by facilities identified in subsections (a) and (b) to operate under a permit-by-rule:

   (1)  The facility complies with Chapter 285 and Subchapters E and F (relating to storage, collection and transportation of municipal waste; storage; collection and transportation).

   (2)  The facility has necessary permits under the environmental protection acts, and is operating in accordance with the environmental protection acts and the regulations promulgated thereunder, the terms and conditions of permits and orders of the Department.

   (3)  The operator maintains at the facility in a readily accessible place the following information:

     (i)   For a processing facility identified in subsection (a), a written plan for managing infectious waste generated at the facility, including waste handling, equipment operation and maintenance, processing method, disinfection monitoring procedures including quality assurance procedures, and a description of how noninfectious waste is managed to prevent commingling.

     (ii)   For processing facilities subject to a permit-by-rule, daily records of the weight or volume of the waste that is processed, the method and location of disposal facilities for wastes from the processing facility, and waste handling problems and emergencies.

   (4)  Processing does not have an adverse effect on public health, safety, welfare or the environment.

   (5)  The waste is disinfected in accordance with §  284.321 (relating to infectious waste monitoring requirements).

   (6)  Disinfection occurs before or during processing of the waste.

   (7)  A log is maintained for each disinfection unit and is made available to the Department upon request. The log shall record the following:

     (i)   The date, time and operator for each use.

     (ii)   The dates and results of calibration.

     (iii)   The postdisinfection color reading of temperature sensitive tape and the results of biological indicator spore testing, in accordance with §  284.321 for steam disinfection facilities.

     (iv)   Results of ash testing which utilizes a methodology approved by the Department, for incineration facilities.

   (8)  Remaining waste is managed in accordance with the act and the regulations promulgated thereunder. For onsite autoclave facilities which do not render the waste unrecognizable, the processing residue shall be manifested in accordance with Subchapter H (relating to manifesting for infectious and chemotherapeutic waste).

   (9)  For incineration facilities, an air quality permit shall be obtained under the Air Pollution Control Act (35 P. S. § §  4001—4015).

   (10)  For facilities identified in subsection (a), notice is provided to the Department by the operator of a facility which indicates an intention to operate under permit-by-rule and which includes the following information:

     (i)   The name and address of the facility.

     (ii)   A description of the processing activity.

     (iii)   The names and telephone numbers of the individuals responsible for operation of the processing facility.

   (11)  For facilities identified in subsection (a), the processed waste is disposed of in a landfill or processed in an incinerator that has obtained written approval from the Department to dispose or process the waste.

 (d)  Chapter 271, Subchapter E (relating to civil penalties and enforcement) is applicable to facilities subject to permit-by-rule.

 (e)  Notwithstanding a provision in this section to the contrary, a facility will not be deemed to have a permit-by-rule if it causes or allows violations of the environmental protection acts, the regulations promulgated thereunder, the terms or conditions of a permit issued by the Department, or an order issued by the Department, or causes a public nuisance. A facility that is subject to permit-by-rule is not required to apply for a permit under this article, if that facility operates in accordance with this section.

 (f)  Generators who qualify for a permit-by-rule may render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.

 (g)  The requirements under Chapter 271, Subchapter D (relating to financial assurances requirements) which relate to bonding and insurance are waived for facilities which are deemed to have a permit under this section.