[44 Pa.B. 7021]
[Saturday, November 8, 2014]
[Continued from previous Web Page]
Subchapter B. GENERAL REQUIREMENTS FOR PERMITS AND PERMIT APPLICATIONS
REQUIREMENT § 271.101. Permit requirement.
(a) Except as provided in subsection (b), a person or municipality may not own or operate a municipal waste disposal or processing facility unless the person or municipality has first applied for and obtained a permit for the facility from the Department under the requirements of this article.
(b) A person or municipality is not required to obtain a permit:
(1) For the use or application of agricultural waste in normal farming operations, unless the proposed use or application of the waste may cause pollution to air, water or other natural resources of this Commonwealth.
(2) For a source separation and collection program for recycling municipal waste, or for dropoff points, or collection or processing centers for source separated recyclable materials.
(3) For the use as clean fill of the following materials if they are separate from other waste:
(i) Uncontaminated soil, rock, stone, gravel, unused brick and block and concrete.
(ii) Waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material.
(4) For the use of waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material if the waste is not hazardous. A person managing waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material, shall implement best management practices. The Department will prepare a manual for the management of waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material which identifies best management practices and may approve additional best management practices on a case-by-case basis. If a person fails to implement best management practices for managing waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material, the Department may require compliance with the disposal, composting, processing and storage operating requirements of this chapter and Chapters 281, 283 and 285 (relating to composting facilities; resource recovery and other processing facilities; and storage, collection and transportation of municipal waste).
(c) Subsection (b) does not relieve a person or municipality of the requirements of an applicable environmental protection act or an applicable regulation promulgated under it. Notwithstanding subsection (b), the Department may require a person or municipality to apply for, and obtain, an individual or general solid waste permit, or take other appropriate action, when the person or municipality is conducting a solid waste activity that harms or presents a threat of harm to the health, safety or welfare of the people or the environment of this Commonwealth.
§ 271.103. Permit-by-rule for municipal waste processing facilities other than for regulated medical or chemotherapeutic waste; qualifying facilities; general requirements.
(a) Purpose. Facilities and activities described in this section shall be deemed to have a municipal waste permit by rule if the following general requirements are met:
* * * * *
EXISTING FACILITIES § 271.114. (Reserved).
Subchapter E. CIVIL PENALTIES AND ENFORCEMENT
ENFORCEMENT § 271.421. Administrative inspections.
* * * * * (c) The Department, its employees and agents intend to conduct inspections under the act of:
(1) Facilities for the agricultural utilization of sewage sludge operating under a permit issued under Chapter 275 (relating to land application of sewage sludge) or a beneficial use order issued prior to January 25, 1997, at least two times per year.
(2) Municipal waste processing facilities other than resource recovery facilities, which process or incinerate regulated medical or chemotherapeutic waste, at least two times per year.
(3) Municipal waste processing facilities other than resource recovery facilities, which do not process or incinerate regulated medical or chemotherapeutic waste, at least once per year.
(4) Hospitals where regulated medical or chemotherapeutic waste is generated, at least two times per year.
(5) Locations other than hospitals where regulated medical or chemotherapeutic waste is generated, at least once per year.
(6) Facilities subject to permit-by-rule under § 271.102 (Reserved) at least once per year.
(7) Facilities and beneficial use areas subject to permit-by-rule under § 271.103 (relating to permit-by-rule for municipal waste processing facilities other than for regulated medical or chemotherapeutic waste; qualifying facilities; general requirements), a general permit for beneficial use or processing, or both, under Subchapter I (relating to beneficial use), or a permit for the land application of sewage sludge under Subchapter J (relating to beneficial use of sewage sludge by land application), at least once per year.
* * * * *
Subchapter G. RESIDUAL WASTE
GENERAL PROVISIONS § 271.601. Scope.
(a) This subchapter applies to municipal waste processing or disposal facilities that apply to receive residual waste for processing or disposal. Section 271.611 (relating to chemical analysis of waste) also applies to an application for a general permit for the beneficial use or processing of municipal waste under Subchapter I (relating to beneficial use). This subchapter does not apply to:
(1) Transfer facilities except as otherwise required in writing by the Department.
(2) The disposal at permitted municipal waste landfills of residual waste from a person or municipality that generates a total quantity of 2,200 pounds or less of residual waste per generating location in each month, if the application demonstrates to the Department's satisfaction that the waste is not hazardous.
(3) The disposal at permitted municipal waste landfills of an individual type of residual waste from a person or municipality that generates a total of 2,200 pounds or less of that type of residual waste per generating location in each month, if approved by the Department in writing.
(b) The requirements of this subchapter are in addition to the application and operating requirements in this article.
(c) The Department may require analyses under this subchapter for special handling waste other than sewage sludge, regulated medical waste, chemotherapeutic waste and ash residue from a resource recovery facility.
ADDITIONAL APPLICATION REQUIREMENTS § 271.611. Chemical analysis of waste.
* * * * * (f) Waiver. The Department may, in writing, waive the requirements of this section for special handling waste, waive or modify the requirements of this section for general permits issued under Subchapter I and waive or modify the chemical analysis requirements under § 271.103 (relating to permit-by-rule for municipal waste processing facilities other than for regulated medical or chemotherapeutic waste; qualifying facilities; general requirements).
Subchapter I. BENEFICIAL USE
SCOPE § 271.801. Scope.
(a) This subchapter sets forth requirements for general permits for the processing and beneficial use of municipal waste, except as follows:
(1) This subchapter does not set forth requirements for general permits for the processing or beneficial use of regulated medical or chemotherapeutic waste.
(2) This subchapter does not set forth requirements for general permits for the beneficial use of sewage sludge by land application, except as provided in § 271.821(b)(6) (relating to application for general permit). A general or individual permit for the beneficial use of sewage sludge not mixed with residual waste will be issued only under Subchapter J (relating to beneficial use of sewage sludge by land application).
(b) An operation that is approved under this subchapter does not require an individual processing or disposal permit under this article. The requirements of Subchapters A—G and Chapters 273, 277, 279, 281, 283 and 285 are applicable to the extent required in § 271.832 (relating to waiver and modification of requirements).
GENERAL PERMIT FOR PROCESSING OR BENEFICIAL USE, OR BOTH, OF MUNICIPAL WASTE; AUTHORIZATION AND LIMITATIONS § 271.811. Authorization for general permit.
(a) Under §§ 271.812 and 271.821—271.825, the Department may issue general permits on a regional or Statewide basis for a category of processing when processing is necessary to prepare the waste for beneficial use, or for a category of beneficial use, or both, of municipal waste, if the following are met:
(1) The wastes included in the category are generated by the same or substantially similar operations and have the same or substantially similar physical character and chemical composition. If wastes are not the same or substantially similar and are blended for use, the blend shall be consistently reproduced with the same physical character and chemical composition.
(2) The wastes included in the category are proposed for the same or substantially similar beneficial use or processing operations.
(3) The activities in the category can be adequately regulated utilizing standardized conditions without harming or presenting a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth. The Department will not issue a general permit if the use of the waste as an ingredient in an industrial process or as a substitute for a commercial product presents a greater harm or threat of harm than the use of the produce or ingredient which the waste is replacing.
(b) The Department may issue a general permit upon its own motion under § 271.825 (relating to Department initiated general permits) or upon an application from a person or municipality under §§ 271.821—271.824.
(c) The Department may modify, suspend, revoke, issue or reissue a general permit or coverage under a general permit under this subchapter as it deems necessary to prevent harm or the threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.
(d) The Department may modify, suspend, revoke, issue or reissue a general permit or coverage under a general permit under this subchapter as it deems necessary to prevent violation of or interference with the laws or solid waste management plans of any state, county or municipality.
(e) The Department may issue a general permit for processing combinations of municipal and residual wastes when processing is necessary to prepare a waste for beneficial use, or for beneficial use of combinations of municipal and residual wastes, or both, under this article or Article IX (relating to residual waste management), whichever the Department determines is appropriate. The Department will determine which article is appropriate based on factors including whether the facility is captive or noncaptive, and the proportions of municipal and residual wastes. A general permit for processing or beneficial use of combinations of sewage sludge and residual waste will be issued only under this subchapter.
(f) The requirements in this subchapter that apply to municipal waste also apply to residual waste when residual waste is mixed with municipal waste.
(g) The Department will not issue a general permit under this subchapter for the following:
(1) A municipal waste landfill, the use of municipal waste to fill open pits from coal or noncoal mining, or the use of municipal waste solely to level an area or bring the area to grade unless construction activity is completed on the area promptly after placement of the waste.
(2) A facility or activity which should be covered under the individual permitting process required in this article because of its size and potential to affect the environment adversely or because of its relationship to municipal waste management plans.
(3) The processing or beneficial use of regulated medical or chemotherapeutic waste.
(4) The beneficial use of sewage sludge by land application for sewage sludge that is not mixed with residual waste.
(5) The use of a waste for construction or operations at a resource recovery facility or disposal facility.
CHAPTER 272. MUNICIPAL WASTE PLANNING, RECYCLING AND WASTE REDUCTION
Subchapter C. MUNICIPAL WASTE PLANNING
PLAN CONTENT § 272.223. Description of waste.
(a) The plan shall describe and explain the origin, content and weight or volume of municipal waste currently generated within the county's boundaries, and the origin, content and weight or volume of municipal waste that will be generated within the county's boundaries during the next 10 years. The plan shall also include a statement of the county or other geographical area for which the plan is prepared.
(b) In describing the content of waste, the plan shall specifically address sewage sludge (including septage), regulated medical and chemotherapeutic waste, ash from resource recovery facilities, construction/demolition waste other than waste from demolition of an industrial site and other municipal waste.
(c) In describing the origin of waste, the plan shall provide:
(1) An estimate of the number of residential, commercial, municipal and institutional establishments, and community activities within the county, for municipal waste other than the special handling wastes specifically addressed in this subsection.
(2) An inventory of public and private sewage treatment plants, including mobile homes, restaurants and hotels, and an inventory of septage haulers serving the county, for sewage sludge (including septage).
(3) An inventory of hospitals in the county, and a representative sampling of different medical specialists, such as clinics, doctors, dentists, funeral directors and veterinarians, for regulated medical and chemotherapeutic waste.
(4) An inventory of the facilities serving the county, for ash from resource recovery facilities.
(5) An estimate of the amount of construction/demolition waste currently generated within the county's boundaries and that will be generated within the county's boundaries during the next 10 years; and an estimate of the amount of construction/demolition waste that is currently recycled and that could be recycled during the next 10 years.
(d) In describing the weight or volume of waste, the plan shall provide:
(1) A total waste generation estimate for the planning area derived from best available National studies, sampling data from similar counties or other reliable information, for municipal waste other than special handling waste described in subsection (c).
(2) Sampling or survey data for the planning area, or other reliable information, for the special handling waste described in subsection (c).
(3) A detailed analysis, for each type of waste, of the extent to which recycling currently reduces the weight or volume of waste that requires processing or disposal, and the extent to which waste reduction or recycling will reduce the weight or volume of waste that will require processing or disposal within the next 10 years. If less than 35% of the weight or volume of waste will be recycled or reduced, the plan shall contain a detailed justification.
(e) The plan may also, at the discretion of the county, specifically address one or more of the following:
(1) Waste tires.
(2) Household hazardous waste.
(3) Leaf waste, yard waste and other waste suitable for composting.
(4) Bulk items from community cleanup days.
(5) Other components of municipal waste not described in this section.
Subchapter F. HOUSEHOLD HAZARDOUS WASTE COLLECTION, TRANSPORTATION AND MANAGEMENT
OPERATION OF PROGRAMS § 272.532. Limitations on acceptable waste.
(a) The following wastes may not be accepted at a collection event:
(1) Radioactive material.
(2) Regulated medical waste, and hypodermic needles or syringes.
(3) Explosives.
(b) An eligible entity may not deposit more than 1,000 kilograms (2,200 pounds) of waste at an individual collection event. The collection contractor shall weigh waste received at a collection event to ensure that no entity deposits more than 1,000 kilograms of waste at an individual collection event. A sponsor may lower the maximum amount of waste that may be deposited by an eligible entity.
CHAPTER 273. MUNICIPAL WASTE LANDFILLS
Subchapter D. ADDITIONAL APPLICATION REQUIREMENTS FOR SPECIAL HANDLING AND RESIDUAL WASTES
SPECIFIC WASTES § 273.411. Processed regulated medical or chemotherapeutic waste disposal.
(a) An application for the disposal of processed regulated medical or chemotherapeutic waste shall contain necessary plans and specifications showing how the applicant will comply with § 273.511 or § 273.512 (relating to processed regulated medical waste disposal; and chemotherapeutic waste), or both, whichever is applicable.
(b) The application, on a form provided by the Department, shall contain the following information:
(1) The name and location of the generator of the waste.
(2) A description of the origin and content of the waste, its containerization and the expected volume and frequency of waste disposal at the facility.
(3) A description of the facility where the waste will be disinfected prior to disposal, including its name and location. For a permitted processing facility that is not operating under a permit by rule under Chapter 271, Subchapter B (relating to general requirements for permits and permit applications), the applicant shall provide the permit number.
(4) A description of the processing methods to be used for each type of waste, including, when necessary, schematic drawings.
(5) A description of the containers to be used for storage during collection and during movement within the facility, including the length of storage.
(6) A description of the alternatives to be used if the processing equipment is inoperable, and the procedures to be used for storage of the waste if it cannot be promptly processed.
(7) A description of handling and safety measures that will be employed for each type of waste, including personal protection and safety as well as modifications to the operational safety plan that are required.
(8) If disinfection will be employed, a description of the monitoring and quality assurance program to ensure proper disinfection.
(9) A description of modifications to an existing processing facility that are required to process the waste, including drawings.
(10) A certification indicating that the waste to be disposed is noninfectious. The certification shall include the method of processing, indicator test results and testing frequency.
Subchapter E. ADDITIONAL OPERATING REQUIREMENTS FOR SPECIAL HANDLING AND RESIDUAL WASTES
SPECIFIC WASTES § 273.511. Processed regulated medical waste disposal.
(a) Regulated medical waste may not be disposed of at a municipal waste landfill unless:
(1) The waste has been disinfected in accordance with § 284.321 (relating to regulated medical waste monitoring requirements).
(2) Prior to initial disposal the landfill operator has obtained the necessary approval for disposal from the Department based on the application provided under § 273.411 (relating to processed regulated medical or chemotherapeutic waste disposal).
(3) The waste being received has been disinfected by a permitted processing facility.
(b) Waste consisting of human anatomical remains, including human fetal remains, may not be disposed at municipal waste landfills unless the waste has first been incinerated at a permitted waste processing facility.
(c) Body fluids and animal body fluids may be disposed by discharge into a permitted sewage treatment system that provides a minimum of secondary treatment in accordance with local, Federal and State requirements, including The Clean Stream Law (35 P. S. §§ 691.1—691.1001).
(d) Used sharps and unused hypodermic needles or syringes shall be rendered incapable of being reused prior to disposal.
CHAPTER 284. REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE
Subchapter A. GENERAL PROVISIONS
GENERAL PROVISIONS § 284.1. Scope.
This chapter sets forth application and operating requirements for a person or municipality that operates a regulated medical or chemotherapeutic waste facility. The requirements in this chapter are in addition to the applicable requirements in Chapters 271, 283 and 285 (relating to municipal waste management—general provisions; resource recovery and other processing facilities; and storage, collection and transportation of municipal waste).
§ 284.2. Permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements.
(a) The following processing facilities for regulated medical and chemotherapeutic waste will be deemed to have a municipal waste processing permit under this article if the following requirements in this subsection and subsection (c) are met:
(1) A processing facility with an autoclave if the following requirements are met:
(i) The facility processes at least 50% of its own regulated medical waste. The facility may not accept more than 50% of regulated medical waste for disinfection from small quantity generators that generate less than 220 pounds per month.
(ii) The facility does not process pathological waste or chemotherapeutic waste.
(iii) The facility may additionally process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.
(iv) The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.
(v) The operator of the facility provides notice to the Department that includes the following:
(A) An intention to operate under permit-by-rule.
(B) The name and address of the facility.
(C) A description of the processing activity.
(D) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(2) A processing facility with an incinerator if the following requirements are met:
(i) The facility processes at least 50% of its own regulated medical or chemotherapeutic waste. The facility may not accept more than 50% of regulated medical or chemotherapeutic waste for disinfection from small quantity generators that generate less than 220 pounds per month.
(ii) The facility may process other municipal waste generated onsite if the resulting ash is managed as processed regulated medical or chemotherapeutic waste.
(iii) The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.
(iv) The operator of the facility provides notice to the Department that includes the following:
(A) An intention to operate under permit-by-rule.
(B) The name and address of the facility.
(C) A description of the processing activity.
(D) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(3) A processing facility with steam and superheated water disinfection if the following requirements are met:
(i) The facility processes at least 50% of its own regulated medical waste. The facility may not accept more than 50% of regulated medical waste for disinfection from small quantity generators that generate less than 220 pounds per month.
(ii) The facility does not process pathological waste or chemotherapeutic waste.
(iii) The facility may additionally process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.
(iv) The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.
(v) The operator of the facility provides notice to the Department that includes the following:
(A) An intention to operate under permit-by-rule.
(B) The name and address of the facility.
(C) A description of the processing activity.
(D) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(4) Onsite processing of liquid blood and body fluids using a glutaraldehyde-based or hypochlorite-based product that encapsulates or converts liquid blood or body fluids into solids or gels so that no free liquids remain. The Department may approve the use of other disinfectant-based products under these provisions if their efficacy can be demonstrated. The processed liquid blood and body fluids may be disposed of at a municipal waste landfill provided:
(i) No free liquids remain in the processed waste.
(ii) The landfill has received written approval from the Department authorizing disposal of the processed liquid blood and body fluids.
(iii) The facility does not process chemotherapeutic waste.
(5) Transfer facilities that temporarily store regulated medical or chemotherapeutic waste for less than 72 hours provided the stored waste remains in its original packaging, is not putrescent and does not attract vectors.
(b) Generators that process and disinfect less than 220 pounds per month of regulated medical waste onsite and render the waste unrecognizable will be deemed to have a municipal waste processing permit under this article if the requirements under subsection (c) are met. Generators that process and disinfect less than 220 pounds per month of regulated medical waste onsite without rendering the waste unrecognizable will be deemed to have a municipal waste processing permit under this article if the following requirements under this subsection and subsection (c) are met:
(1) The generator shall dispose of the processed waste in a landfill or have the waste incinerated in a facility that has written approval from the Department to accept this type of waste.
(2) The generator shall comply with the log and shipping paper requirements in § 284.701(b)(5) (relating to scope).
(c) The following requirements shall be met by facilities identified in subsections (a)(1)—(4) and (b) to operate under a permit-by-rule:
(1) The facility complies with Subchapters E and F (relating to segregation and storage; and collection and transportation) and Chapter 285 (relating to storage, collection and transportation of municipal waste).
(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 regulated medical waste generated at the facility, including waste handling, equipment operation and maintenance, processing method, disinfection monitoring procedures including quality assurance procedures, frequency of calibration 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 regulated medical 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 that do not render the waste unrecognizable, the treated or processed regulated medical waste shall be transported in accordance with Subchapter H (relating to tracking of regulated medical and chemotherapeutic waste).
(9) For incineration facilities, an air quality permit shall be obtained as required under the Air Pollution Control Act (35 P. S. §§ 4001—4015).
(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) The requirements under Chapter 271, Subchapter D (relating to financial assurances requirements) that relate to bonding and insurance are waived for facilities that are deemed to have a permit under this section.
§ 284.3. Regulated medical or chemotherapeutic waste aggregation facilities.
(a) Applicability. This section applies to operators of regulated medical or chemotherapeutic waste aggregation facilities.
(b) Permit-by-rule for regulated medical or chemotherapeutic waste aggregation facilities. The operator of an aggregation facility may operate under a permit-by-rule. For the operation of a regulated medical or chemotherapeutic waste aggregation facility to be authorized by a permit-by-rule, the owner or operator shall:
(1) Comply with the generator standards in Subchapter E (relating to segregation and storage).
(2) Only accept the following regulated medical or chemotherapeutic waste generated:
(i) Onsite or offsite by the operator of the aggregation facility.
(ii) By physicians in their independent practices or other medical personnel within the same building or complex of buildings.
(c) Noncompliance. The Department may require the operator of an aggregation facility operated under permit-by-rule to apply for and obtain a permit, or take other appropriate action, when the operator is not in compliance with the requirements for the permit-by-rule or is conducting an activity that harms or presents a threat of harm to the health, safety or welfare of the people or the environment.
Subchapter B. GENERAL PERMITS
GENERAL § 284.101. Authorization for general permits.
(a) In accordance with this subchapter, the Department may issue general permits on a regional or Statewide basis for a category of mobile or stationary regulated medical waste processing facilities or stationary chemotherapeutic waste processing facilities if the Department determines the following:
(1) The processing facilities and the waste to be processed in the category are substantially similar.
(2) The processing facilities in the category can be adequately regulated utilizing standard conditions without harming or presenting a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.
(3) The processing facilities in the category will comply with the requirements established in the permit and with the standards and requirements for design, construction, operation, maintenance and monitoring in Chapter 283 (relating to resource recovery and other processing facilities) and Subchapter D (relating to processing facilities).
(b) The Department may issue a general permit upon its own motion under § 284.115 (relating to Department-initiated general permits) or upon an application from a person or municipality under §§ 284.111—284.114.
(c) The Department may issue a general permit for the mixing of disinfection products with regulated medical waste to perform processing.
(d) The Department may issue a general permit for the processing of mixtures of the same types of waste that are regulated medical or residual wastes.
(e) The Department may modify, suspend, revoke or reissue general permits under this subchapter as it deems necessary to prevent harm or the threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.
(f) The Department will not issue a general permit for a commercial regulated medical or chemotherapeutic waste processing facility, including commercial incinerators.
§ 284.102. Nature of a general permit; substitution for individual applications and permits.
(a) When the Department issues a general permit for a regulated medical or chemotherapeutic waste processing facility on either a regional or Statewide basis, persons or municipalities who intend to process regulated medical or chemotherapeutic waste in accordance with the terms and conditions of the general permit may do so without filing an individual application for, and first obtaining, an individual permit.
(b) The use of an applicable general permit shall satisfy the requirement to obtain a permit in § 271.101 (relating to permit requirement) if the following are met:
(1) The processing activities are conducted in accordance with the terms and conditions of the applicable general permit.
(2) The person or municipality conducting the processing activities is authorized to operate under the general permit at the time that the Department issued the general permit or under the applicable general permit in accordance with § 284.133 (relating to registration).
(c) Notwithstanding subsections (a) and (b), the Department may require a person or municipality authorized by a general permit to apply for, and obtain, an individual permit if a general permit is not available to conduct an activity, when the person or municipality is not in compliance with the conditions of a general permit or is conducting an activity that harms or presents a threat of harm to the health, safety or welfare of the people or the environment of this Commonwealth.
ISSUANCE OF A GENERAL PERMIT § 284.111. Application for general permit.
(a) A person or municipality may apply to the Department for the issuance of a general permit for a specific category of processing of regulated medical or chemotherapeutic waste.
(b) An application for the issuance of a general permit for processing regulated medical or chemotherapeutic waste shall be submitted on a form prepared by the Department and shall contain the following:
(1) A description of the waste.
(2) A characterization of the waste as either regulated medical or chemotherapeutic.
(3) An operation plan which contains the following:
(i) A description of the proposed processing activity and equipment.
(ii) A description of the method proposed to receive regulated medical or chemotherapeutic waste which ensures the waste is handled separately from other solid waste until processing and disposal, and that prevents unauthorized persons from having access to or contact with the waste.
(iii) A description of the procedure for managing containers which arrive in a leaking condition, which includes whether the waste is processed immediately, repacked or rejected.
(iv) A description of the method proposed to unload and process regulated medical or chemotherapeutic waste, limiting the number of persons handling the waste and minimizing the possibility of exposure of that waste to employees and the public using or visiting the facility.
(v) A description of the method proposed for disinfecting emptied, reusable regulated medical waste containers, transport vehicles and facility equipment which are known or suspected to be contaminated with regulated medical waste.
(vi) A description of the method proposed for handling and disposal of regulated medical or chemotherapeutic waste containers which cannot be reused.
(vii) A description of reuse of containers if the surfaces of the containers have been protected from direct contact with chemotherapeutic waste.
(viii) A description of the means by which provisions will be made to require the use of clean gloves and clean uniforms along with other protective clothing to provide protection of employees against exposure to regulated medical or chemotherapeutic waste.
(ix) A description of the means by which provisions will be made to require decontamination of a person having had bodily contact with regulated medical or chemotherapeutic waste while handling that waste at the facility.
(x) A description of the method proposed to quantify, on a weight basis, the maximum amount of regulated medical or chemotherapeutic waste to be stored and processed each month.
(xi) A schedule of the operating hours of the facility.
(xii) A description of the method proposed to assure that regulated medical or chemotherapeutic waste received at the facility is consistent with § 283.201 (relating to basic limitations).
(xiii) A description of periodic testing using biological indicators which demonstrate effective disinfection of the waste, in accordance with § 284.321 (relating to regulated medical waste monitoring requirements).
(xiv) A description of closure activities which are proposed to be carried out upon cessation of operations, in accordance with § 283.272 (relating to cessation of operations).
(xv) A description of how the processing residue will be managed.
(xvi) A description of how aerosols will be minimized and controlled during processing activities.
(4) A contingency plan which provides procedures to be used for emergency situations including, at a minimum, spills of regulated medical or chemotherapeutic waste and ruptures of containers containing the waste. The plan shall include procedures for cleanup and disinfection of spill area, protection of personnel, disposal of spill residue and repackaging of the waste. The plan shall also include a description of an alternative waste handling system during periods when the proposed facility is not in operation, including procedures to be followed in the case of equipment breakdown. Alternate waste handling procedures may include use of standby equipment, extension of operating hours and contractual agreements for diversion of regulated medical or chemotherapeutic waste to other facilities.
(5) A personnel training plan which describes the hiring of equipment operators and the training of personnel involved in the handling and processing of regulated medical or chemotherapeutic waste. The plan shall include a detailed explanation of the operation and contingency plans.
(c) A nonrefundable fee in the form of a check payable to the ''Commonwealth of Pennsylvania'' for $1,000 shall accompany the application.
(d) The application requirements in subsection (b) may be waived or modified for the mixing of disinfection products with regulated medical waste to perform processing.
§ 284.112. Completeness review.
(a) After receipt of an application for the issuance of a general permit, the Department will determine whether the application is administratively complete. For purposes of this subchapter, an application is administratively complete if it contains the necessary analyses, fees, documents and information, regardless of whether the analyses, fees, documents and information would be sufficient for the issuance of the permit.
(b) If the application is not administratively complete, the Department will return it to the applicant, within 60 days of receipt of the application. A written statement of the specific analyses, fees, documents or information that are required to make the application administratively complete will accompany an application which is returned.
(c) The Department will deny the application if the applicant fails to provide the analyses, fees, documents and information within 90 days of receipt of the notice in subsection (b).
§ 284.113. Public notice and review period.
(a) The Department will publish notice of receipt of an application for a general permit in the Pennsylvania Bulletin when the Department determines that the application is administratively complete.
(b) The notice shall include:
(1) A brief description of the waste and the category of processing of regulated medical or chemotherapeutic waste which is identified in the application as a candidate for a general permit.
(2) The Department's address and telephone number at which interested persons or municipalities may obtain further information and review a copy of the application for the general permit.
(3) A brief description of the procedures for public comment on the general permit application.
(4) A statement that interested persons or municipalities may submit comments to the Department within 60 days of the publication of the notice, and may recommend conditions upon, revisions to, approval or disapproval of the general permit application.
(c) The Department may hold a public meeting or public hearing on the application for a general permit.
(d) Upon issuance of a general permit, the Department will place a notice in the Pennsylvania Bulletin of the availability of the general permit. If a county has made recommendations to the Department concerning conditions, revisions or disapproval of the permit during the 60-day comment period, and the Department has overridden the recommendations, the Department will publish its justification for overriding the recommendations in the Pennsylvania Bulletin.
(e) Each applicant for coverage under the general permit shall provide written notice to each municipality in which the applicant intends to operate under a general permit.
§ 284.114. Approval or denial of an application.
The Department may not issue a general permit for a category of processing of regulated medical or chemotherapeutic waste unless the applicant has affirmatively demonstrated the following:
(1) The application for the general permit is accurate and complete.
(2) The applicant has complied with the requirements of §§ 284.101, 284.102 and 284.111—284.113.
(3) The proposed processing activities will be conducted in a manner that will not harm or present a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth through exposure to constituents of the waste during the processing activities and afterwards.
§ 284.115. Department-initiated general permits.
(a) The Department may issue or modify a general permit for a category of processing of regulated medical or chemotherapeutic waste upon its own motion in accordance with this section.
(b) At least 60 days prior to the issuance or modification of a general permit under this section, the Department will publish a notice in the Pennsylvania Bulletin of intent to issue or modify a general permit under this section.
(c) The notice required by subsection (b) will include the following:
(1) A clear and specific description of the category of processing of regulated medical or chemotherapeutic waste eligible for coverage under the proposed general permit.
(2) The standards in § 284.101(a) (relating to authorization for general permits), and a brief description of the reasons for the Department's determination that the category of processing is eligible for coverage under a general permit in accordance with these standards.
(3) A brief description of the terms and conditions of the proposed general permit.
(4) A brief description of the procedures for public comment on the general permit in accordance with this subchapter.
(5) The Department address and telephone number at which interested persons or municipalities may obtain further information and review a copy of the proposed general permit.
(6) A statement that interested persons or municipalities may submit comments to the Department within 60 days of the publication of the notice and may recommend conditions upon, revisions to, and approval or disapproval of the proposed general permit.
(d) The Department may hold a public meeting or public hearing on the proposed general permit or proposed modification to the general permit.
(e) Upon issuance or modification of a general permit, the Department will place a notice in the Pennsylvania Bulletin of the availability of the new or modified general permit.
§ 284.116. General permit renewal.
(a) A person or municipality that plans to process regulated medical or chemotherapeutic waste after the expiration of the term in the general permit shall file notice to the Department of intent to continue operating under the permit at least 180 days before the expiration date of the permit. The notice must include updated registration information on forms provided by the Department, a check payable to the ''Commonwealth of Pennsylvania'' for $250 and any suggested changes to the terms or conditions of the permit.
(b) A permit renewal may include all persons or municipalities that have applied for renewal within the time period provided in subsection (a). A person or municipality that does not meet the time period in subsection (a) shall be required to register under a renewed general permit.
(c) At least 120 days prior to the permit expiration, the Department will provide public notice of the permit renewal along with an update of the terms or conditions in accordance with the public notice requirements of § 284.115 (relating to Department-initiated general permits.)
(d) General permits will be renewed for a maximum term of 10 years.
(e) If the Department is unable to reissue the general permit prior to its expiration date, the Department may extend the term of a general permit for a period not to exceed 1 year for any permittee that is operating in compliance with the terms and conditions of the general permit and the environmental statutes and regulations of the Commonwealth.
CONTENT OF GENERAL PERMITS AND WAIVERS OR MODIFICATIONS § 284.121. Contents of general permits.
Each general permit issued by the Department will include, at a minimum:
(1) A clear and specific description of the category of processing of regulated medical or chemotherapeutic waste eligible for coverage under the general permit.
(2) The standards in § 284.101(a) (relating to authorization for general permits) and a brief explanation of the reasons for the Department's determination that the category of processing is eligible for coverage under the general permit in accordance with the standards in § 284.101(a).
(3) A specification of registration requirements established in accordance with § 284.131 (relating to authorization for persons or municipalities to be included in a general permit) and the fee imposed on registrants for coverage under the general permit.
(4) An effective date, and a fixed permit term, which may not exceed 10 years from the effective date. If the Department renews a general permit, the term may not exceed the term of the original permit.
(5) A set of terms and conditions governing the construction, operation, maintenance, inspection and monitoring of the processing activities covered by the general permit as are necessary to assure compliance with this act, this article and the environmental protection acts.
(6) A requirement that persons or municipalities who conduct activities authorized by the general permit shall allow authorized representatives of the Commonwealth, without advance notice or a search warrant, upon the presentation of appropriate credentials, and without delay, to have access to areas in which the activities covered by the general permit will be, are being or have been conducted to ensure compliance with the act and the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. §§ 6019.1—6019.6), known as the Infectious and Chemotherapeutic Waste Law, regulations promulgated thereunder and a permit, license or order issued by the Department under the act.
(7) A requirement that the activities authorized by the general permit will not harm or present a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.
(8) A requirement that waste be accompanied by a properly completed log or shipping paper, in accordance with Subchapter H (relating to tracking of regulated medical and chemotherapeutic waste).
(9) A requirement that waste be delivered by a licensed transporter in accordance with Subchapter G (relating to transporter licensing for regulated medical and chemotherapeutic waste), when appropriate.
(10) A requirement that the processing facility operate in accordance with local, State and Federal requirements.
(11) A requirement that the processing residue be managed in accordance with the Solid Waste Management Act (35 P. S. §§ 6018.101—6018.1003) and the regulations promulgated thereunder.
(12) A requirement that an up-to-date list of names, addresses and telephone numbers of employees that have been designated by the permittee to respond to emergencies at the processing facility be maintained at the facility.
(13) A requirement that individual employee training records be maintained at the processing facility.
(14) A requirement for use of additional indicators selected by the Department to monitor the disinfection process.
(15) A requirement that daily records of the weight or volume of the waste processed, the method and location of disposal facilities for wastes from the processing facility and waste handling problems and emergencies be maintained for 3 years.
(16) A requirement that a log be maintained for each disinfection unit for 3 years that records the following:
(i) The date, time and operator for each use.
(ii) The dates and results of calibration.
(iii) The results of biological indicator spore testing.
(iv) Other information that the Department may require relating to the disinfection process.
(17) Requirements for closure.
(18) A prohibition against processing pathological waste or chemotherapeutic waste in an autoclave.
REGISTRATION § 284.131. Authorization for persons or municipalities to be included in a general permit.
(a) A person or municipality is authorized to operate under a general permit if the person or municipality has registered in accordance with the terms of the general permit and the requirements of this subchapter.
(b) Registration requirements and time limits, if any, will be set forth in the general permit governing each category of processing regulated medical or chemotherapeutic waste. The general permit will also set forth the area or region within which each category of processing is allowed.
(c) At a minimum, the registration must include:
(1) The name, address and location of the person or municipality conducting the activity covered under the general permit.
(2) A description of the waste, including a characterization of the waste as either regulated medical or chemotherapeutic, that will be processed in accordance with the general permit.
(3) A description of the proposed method of processing of the waste.
(4) The name or number of the general permit being utilized for the activity.
(5) A demonstration that the activities which the person or municipality intends to conduct are authorized by the general permit.
(6) A signed and notarized statement by the person or municipality conducting the activity authorized by the general permit, on a form prepared by the Department, which states that the person or municipality agrees to accept the conditions imposed by the general permit for processing of regulated medical or chemotherapeutic waste under the general permit.
(d) A person or municipality that registers for coverage under a general permit shall submit a copy of the registration to each municipality in which the processing activity will be located. The submission shall occur at the same time that the person or municipality files the registration with the Department.
§ 284.132. (Reserved).
Subchapter C. TRANSFER FACILITIES § 284.201. Scope.
This subchapter sets forth application and operating requirements for a person or municipality that operates a transfer facility for regulated medical or chemotherapeutic waste. The requirements in this subchapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management—general provisions).
§ 284.210. Application requirements.
An application to operate a transfer facility shall comply with §§ 279.101—279.111.
§ 284.220. Operating requirements.
A person or municipality that operates a transfer facility shall comply with Chapter 279, Subchapters A and C (relating to general; and operating requirements for transfer facilities).
§ 284.230. Storage requirements.
A transfer facility may store regulated medical or chemotherapeutic waste for up to 72 hours provided that the stored waste remains in its original packaging, is not putrescent and does not attract vectors.
Subchapter D. PROCESSING FACILITIES § 284.301. Scope.
This subchapter sets forth application and operating requirements for a person or municipality that operates a processing facility, other than a transfer or composting facility, for regulated medical or chemotherapeutic waste. The requirements in this subchapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management—general provisions).
§ 284.311. Plan for monitoring.
An application for a processing facility for regulated medical waste shall contain a plan, including necessary designs, procedures and test protocols on forms provided by the Department, for meeting the requirements of § 284.321 (relating to regulated medical waste monitoring requirements), including the following:
(1) The method by which disinfection will be accomplished.
(2) A description of the monitoring and quality assurance program to ensure disinfection.
§ 284.320. Operating requirements.
A person or municipality that operates a processing facility shall comply with Chapter 283, Subchapter C (relating to operating requirements).
§ 284.321. Regulated medical waste monitoring requirements.
(a) A person or municipality that disinfects regulated medical 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 mycobacteria at a 6 log 10 reduction or greater.
(ii) The process shall be capable of inactivating Geobacillus stearothermophilus spores, Bacillus pumilus or Bacillus atrophaeus spores at a 4 log 10 reduction or greater.
(b) The operator of a facility that incinerates or thermally processes regulated medical 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, annually during the life of the facility.
(c) The operator of a facility that incinerates regulated medical 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 regulated medical 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 Geobacillus stearotherm- ophilus.
(2) For dry heat, gas or chemical disinfection, spores of Bacillus atrophaeus 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 within the load where disinfection will be most difficult to achieve.
(g) Regulated medical waste will be considered to be infectious 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 regulated medical or chemotherapeutic waste incineration; and storage and containment of processing residue from a regulated medical or chemotherapeutic waste processing 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 regulated medical or chemotherapeutic waste incineration; and transportation of processing residue from a regulated medical or chemotherapeutic waste facility).
(k) Compactors, grinders or similar devices may not be used to reduce the volume of regulated medical 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 a regulated medical 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) An autoclave facility shall comply with all applicable requirements and is prohibited from processing pathological waste or chemotherapeutic waste.
(n) Unless otherwise approved in writing by the Department, an operator of an autoclave facility shall employ the procedures in § 284.322 (relating to autoclave validation testing requirements) to validate the operating parameters and protocols of the processing equipment. These procedures must be employed at an on-going frequency specified by the manufacturer of the autoclave and in the following circumstances:
(1) When a new autoclave is installed.
(2) When an autoclave is modified, repaired or has experienced a malfunction with respect to hardware, software, controls or ancillary equipment.
(o) The facility shall maintain a record of the autoclave validation testing protocols and procedures.
(p) For facilities engaged in the production or research and development of vaccines or other biologics that are classified under the North American Industrial Classification System as Code 325414—Biological Protocol (except Diagnostic) Manufacturing and who meet the following criteria may utilize the alternate disinfection requirements specified in paragraph (5) instead of the requirements of subsections (a)—(o) to process waste containing an infectious agent classified as Biosafety Level 2 or below, as determined by the protocols established in the most recent edition of the Centers for Disease Control's Biosafety in Microbial and Biomedical Laboratories existing at the time the waste is generated:
(1) Utilize onsite processing facilities at which at least 50% of the waste processed is generated onsite.
(2) Operate in accordance with United States Food and Drug Administration good manufacturing practices or good laboratory practices.
(3) Employ a production process where the infectious agents or biological, or both, are known and well characterized, inactivation criteria are determined and bioburden is measured and controlled including screening for objectionable organisms.
(4) Specify and approve the decontamination process, method and monitoring, and validation procedures for each specific infectious agent in its waste by either of the following:
(i) Establishing and utilizing an Institutional Biosafety Committee constituted in accordance with the Centers for Disease Control and the National Institute of Health guidelines or composed in whole or in part of a panel of experts, a member of which is a biosafety officer certified by the American Biological Safety Association or the American Society for Microbiology or equivalent.
(ii) Retaining a contractor certified by the American Biological Safety Association or the American Society for Microbiology who accepts responsibility for the process, method and procedures that the contractor specified and approves (Independent Certified Biosafety Professional).
(5) The alternate disinfection process must be conducted as follows:
(i) Disinfection shall be conducted by inactivating all waste material in accordance with the practices, methods and minimum parameters for biological kill established by the facility's Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, consistent with the Centers for Disease Control and the National Institute of Health guidelines or scientifically accepted protocols, or both.
(ii) Efficacy of the inactivation operations shall be demonstrated through review of decontamination cycle data by trained technicians or other testing methods or studies specified by the Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, as appropriate for the specific infectious agent or biologic, or both, present in the waste. The procedures for demonstrating the efficacy of the inactivation operations must be set forth in standard operating procedures or other written procedures maintained at the facility, or both.
(iii) Preventative maintenance and calibration programs for decontamination equipment consistent with generally accepted industry standards as specified by the Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, shall be established and routinely implemented.
(q) With the exception of used sharps, which remain subject to the additional requirements of this chapter, regulated medical waste that is generated by manufacturers of vaccines and other biologics who satisfy the criteria of subsection (p)(1)—(4) and decontaminated in accordance with the procedures specified in subsection (p)(5), may be managed, stored, transported and disposed of as ordinary municipal waste and is not subject to any of the additional restrictions or requirements pertaining to special handling waste or regulated medical waste.
§ 284.322. Autoclave validation testing requirements.
Autoclave operating parameters shall be established in accordance with the following:
(1) For facilities with one autoclave or multiple autoclaves that are not identical, each autoclave must have an initial validation test that establishes its operating parameters.
(2) For facilities with multiple autoclaves that are identical, one autoclave may have an initial validation test that establishes the operating parameters for all identical autoclaves at that facility.
(3) Autoclaves shall be tested using the manufacturer's recommended vacuum pulse plan, operating temperature, operating pressure and residence time at the maximum weight and with the most difficult heat transfer challenge anticipated with the indicators located where disinfection would be most difficult to achieve.
(4) If multiple vacuum pulse plans, residence times, temperatures and pressures are recommended, the autoclave shall be tested to validate its performance at each recommended vacuum pulse plan, residence time, temperature and pressure. If a test fails, more stringent operating parameters shall be used incrementally until a satisfactory test and set of operating parameters is determined.
(5) Autoclave operating parameters must be validated to achieve a minimum of 250°F or 121°C measured at a point where disinfection would be most difficult to achieve.
(6) The residence time required to achieve a 6 log 10 reduction of mycobacteria and a 4 log 10 reduction of Geobacillus stearothermophilus spores for the level of heat transfer challenge selected shall be the residence time set into that autoclave's controls.
(7) The vacuum pulse plan, residence time, operating temperature and operating pressure established in the validation test will form the permitted operating parameters for the autoclave tested.
(8) Instead of the temperature, residence time and other requirements of this section, manufacturers of vaccines or other biologics who satisfy the applicability criterion of § 284.321(p) (relating to regulated medical waste monitoring requirements) may establish and validate autoclave operating parameters and residence time based upon the requirements determined by the Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, as necessary to achieve the required disinfection under § 284.321(p)(5)(ii) for the specific infectious agent or biologic, or both, present in the wastes.
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