[30 Pa.B. 6685]
[Continued from previous Web Page]
SOIL AND WATER PROTECTION § 283.231. General requirements.
(a) The operator may not cause or allow a point or nonpoint source discharge in violation of The Clean Streams Law (35 P. S. §§ 691.1--691.1001) from or on the facility to surface waters of this Commonwealth.
(b) A municipal waste processing facility shall be operated to prevent and control water pollution. An operator shall operate and maintain necessary water pollution treatment facilities until water pollution from or on the facility has been permanently abated.
(c) A facility shall be operated to prevent or minimize contact by surface or groundwater with solid waste or processed material.
(d) The operator may not cause or allow water pollution on or off the site.
(e) The operator may not cause contamination of the soil on or off the site.
§ 283.232. Soil erosion and sedimentation control.
The operator shall manage surface water and control erosion and sedimentation to:
(1) Divert surface water away from the storage area with measures and structures necessary to handle surface water flows, based on a 25-year, 24-hour precipitation event, supported by written calculations and also in compliance with Chapter 102 (relating to erosion control).
(2) Meet the requirements of Chapters 102 and 105 (relating to erosion and sediment control; and dam safety and waterway management).
(3) Prevent erosion to the maximum extent possible, including if possible, using revegetation.
§ 283.233. Soil and groundwater monitoring.
(a) If required by the Department as part of the permit, the operator shall conduct soil or groundwater monitoring, or both. The monitoring shall be in accordance with §§ 273.282--273.288 (relating to water quality monitoring), as required by the Department, and the terms and conditions of the permit, and shall continue for the period specified in § 283.272 (relating to cessation of operations).
(b) For purposes of interfacing with §§ 273.282--273.288, the following terms apply:
(1) The term ''disposal area'' shall be substituted with ''area where storage and processing occur.''
(2) The term ''municipal waste landfill'' shall be substituted with ''resource recovery facility or other processing facility.''
(3) The term ''disposed'' shall be substituted with ''stored or processed.''
§ 283.234. Water supply replacement.
(a) A person or municipality operating a municipal waste processing facility subject to this Chapter which adversely affects a water supply by degradation, pollution or other means shall restore or replace the affected water supply with an alternate source that is of like quantity and quality to the original supply at no additional cost to the owner.
(b) A temporary water supply shall be provided as soon as practicable but not later than 48 hours after one of the following:
(1) Receipt of information showing that the operator is responsible for adversely affecting the water supply.
(2) Receipt of notice from the Department that the operator is responsible for adversely affecting the water supply.
(c) A permanent water supply shall be provided as soon as practicable but not later than 90 days after one of the following:
(1) Receipt of information showing that the operator is responsible for adversely affecting the water supply.
(2) Receipt of notice from the Department that the operator is responsible for adversely affecting the water supply.
(d) Permanent water supplies include development of a new well with a distribution system, interconnection with a public water supply, or extension of a private water supply, but do not include provision of bottled water or a water tank supplied by a bulk water hauling system, which are temporary water supplies.
EMERGENCY PROCEDURES § 283.253. Implementation of contingency plan.
(a) The operator of the facility shall immediately implement the applicable provisions of the approved contingency plan whenever there is an emergency. For purposes of this section, an emergency shall include a fire, spill or other hazard that threatens public health and safety, public welfare or the environment and personal injury.
(b) During an emergency, the operator shall:
(1) Assess actual or potential hazards to public health and safety, public welfare and the environment that are occurring or may occur.
(2) Ensure that fires, spills or other hazards do not occur, reoccur or spread to other solid waste at the facility.
(3) Immediately telephone the Department and county emergency management agency, and report the following information:
(i) The name of the person reporting the incident and telephone number where that person can be reached.
(ii) The name, address and permit number of the facility.
(iii) The date, time and location of the emergency.
(iv) A brief description of the nature of the emergency, the type and quantity of the solid waste involved and what dangers to public health and safety, public welfare and the environment exist.
(v) The nature of injuries.
(vi) The parts of the contingency plan being implemented to alleviate the emergency.
(c) After an emergency, the operator of the facility shall do the following:
(1) Clean up the area affected by the emergency and treat, store or dispose of recovered solid waste, contaminated soil, contaminated water or other material in a manner approved by the Department.
(2) Prevent processing, storage or disposal of solid waste in the area affected by the emergency until the operator has cleaned up the area, and the Department has approved the resumption of operation after the cleanup.
RECORDKEEPING AND REPORTING § 283.261. Daily operational records.
(a) The operator of a facility subject to this chapter shall make and maintain an operational record for each day that municipal waste is received, processed or transported offsite.
(b) The daily operational record shall include the following:
(1) The type and weight or volume of the solid waste received.
(2) The county in which the solid waste originated, or if the waste originated outside of this Commonwealth, the state.
(3) The transporters of the solid waste.
(4) The weight or volume of each material recycled or marketed as a result of the process.
(5) For bypassed wastes and waste products, the name and county or state of the facility where the solid waste is ultimately disposed and the weight or volume of waste disposed.
(6) A description of waste handling problems or emergency disposal activities.
(7) A record of deviations from the approved design or operational plans.
(8) A record of activities for which entries are needed in order to comply with the annual operation report required in § 283.262 (relating to annual operation report).
(9) A record of actions taken to correct violations of the act, the environmental protection acts and this title.
(10) A record of rejected waste loads and the reasons for rejecting the loads.
(11) A record of each incident in which radioactive material is detected in waste loads. The record shall include:
(i) The date, time and location of the occurrence.
(ii) A brief narrative description of the occurrence.
(iii) Specific information on the origin of the material, if known.
(iv) A description of the radioactive material involved, if known.
(v) The name, address and telephone numbers of the supplier or handler of the radioactive material and the name of the driver.
(vi) The final disposition of the material.
(12) For resource recovery facilities, a record of each vehicle, other than a combination, that exceeds 73,280 pounds gross weight and of each combination that exceeds 80,000 pounds gross weight.
(i) The record shall include:
(A) The gross weight of the vehicle when weighed at the facility.
(B) The registration plate number and home or base state registration of the vehicle.
(C) The name, business address and telephone number of the owner of the vehicle.
(D) The date and time when the vehicle was weighed at the facility.
(E) The date that the weight scale was last tested in accordance with 3 Pa.C.S. Chapter 41 (relating to the Consolidated Weights and Measures Act).
(ii) For purposes of this paragraph, the following terms have the following meanings, unless the content clearly indicates otherwise:
(A) Combination. Two or more vehicles physically interconnected in tandem. An example of a combination is a truck tractor attached to a semi-trailer.
(B) Gross weight. The combined weight of a vehicle or combination of vehicles and its load, excluding the driver's weight.
(C) Registration. The authority for a vehicle to operate on a highway as evidenced by the issuance of an identifying card and plate or plates.
(c) The operator shall maintain accurate operational records sufficient to determine whether municipal waste is being stored under Chapter 285, Subchapter A (relating to storage of municipal waste).
(d) Daily operational records shall be retained for the life of the facility bond, or longer if determined by the Department to be necessary to meet the standards of the environmental protection acts, but in no case less than 5 years. These records shall be made available to the Department upon request.
§ 283.262. Annual operation report.
(a) An operator of a facility subject to this chapter shall submit to the Department an annual operation report on or before June 30 of each year.
(b) The annual operation report, which shall be submitted on a form supplied by the Department, shall include the following:
(1) A current certificate of insurance, as specified in § 271.374(a) (relating to proof of insurance coverage), evidencing continuous coverage for public liability insurance as required by § 271.371 (relating to insurance requirement).
(2) Changes in the previous year concerning the information required by §§ 271.124 and 271.125 (relating to identification of interests; and compliance information). The report shall state if no changes have occurred.
(3) A change in the ownership of the land upon which the facility is located or a change in a lease agreement for the use of the land that may affect or alter the operator's rights upon the land.
(4) A written update of the total bond liability for the facility under § 271.331 (relating to bond and trust amount determination). If additional bond is determined to be necessary, it shall be submitted to the Department within 90 days after the annual report is due.
(5) Certification that the operator has received all analyses required by § 287.54 (relating to chemical analysis of waste) for each type of residual waste or special handling waste received at the facility during the calendar year.
(6) A record of detected radioactive materials.
(c) The annual operation report shall be accompanied by a nonrefundable annual permit administration fee in the form of a check payable to the ''Commonwealth of Pennsylvania'' for the following amounts:
(1) Seven hundred dollars for facilities that incinerate municipal waste.
(2) Seven hundred dollars for other municipal waste processing facilities subject to this chapter.
§ 283.264. Recycling fee.
(a) On and after October 26, 1988, the operator of a resource recovery facility shall pay the recycling fee, in the form of a check payable to the ''Commonwealth of Pennsylvania, Recycling Fund,'' in accordance with Chapter 7 of the Municipal Waste Planning, Recycling and Waste Reduction Act (53 P. S. §§ 4000.701--4000.706). This fee shall terminate in accordance with law.
(1) The recycling fee shall be paid on a quarterly basis, on or before the 20th day of April, July, October and January for the 3 months ending the last day of March, June, September and December respectively.
(2) A recycling fee payment shall be accompanied by a form provided by the Department and completed according to its instructions and hand signed by the operator.
(b) The fee shall be paid for solid waste received and processed at the facility on and after October 26, 1988, including, but not limited to, residual waste, special handling wastes, waste tires and other solid waste received at the facility. The fee does not apply to the following:
(1) Recyclable or reusable material received and separated from other waste at a collection, transfer, composting or processing facility associated with the facility, and which are marketed in accordance with subsection (d).
(2) Nonprocessible waste received at the facility and disposed at a landfill.
(c) The fee shall be $2 per ton of weighed waste which is received and processed at the facility.
(d) The operator shall maintain complete and accurate records of the weight of materials which are salvaged and recycled from mixed waste after it has been received at the facility, the market where the materials were sent for recycling or reuse, the date that the materials were marketed and the weight of materials actually marketed for recycling. The operator may deduct the weight of materials salvaged and recycled from the facility from the weight of waste for which the fee payment is made, but only for the quarter in which the materials were actually marketed for recycling. These records shall be kept by the operator for 5 years for audit purposes, and shall be made available to the Department or its auditors, or both, on request.
CESSATION AND CLOSURE § 283.272. Cessation of operations.
(a) Upon cessation of processing operations at the facility, the operator shall immediately remove solid waste and structures or other materials which contain or are contaminated with solid waste, and shall provide for the processing or disposal of the waste or material in accordance with the environmental protection acts and this title.
(b) An operator required under § 283.233 (relating to soil and groundwater monitoring) to conduct soil monitoring may discontinue soil monitoring upon cessation of processing operations only upon written approval of the Department. In deciding whether to allow discontinuance of monitoring, the Department will consider the operational history of the facility, the likelihood that soil contamination will manifest itself in the future and other factors.
(c) An operator required under § 283.233 to conduct groundwater monitoring may discontinue groundwater monitoring after cessation of operations and cleanup only upon written approval by the Department. In deciding whether to allow discontinuance of monitoring, the Department will consider the operational history of the facility, the likelihood that groundwater contamination will manifest itself in the future, whether the remediation standards in § 271.342(b)(4) (relating to final closure certification) are met and maintained and other relevant factors.
RECYCLING AND WASTE REMOVAL § 283.281. Salvaging of materials.
(a) A person or municipality may not operate a resource recovery facility unless the operator has developed and is implementing a program to recycle waste materials received at the facility for which recycling is cost effective, in accordance with the plan approval under § 283.121 (relating to recycling plan).
(b) Salvaging and recycling of materials may not be allowed or conducted unless salvaging and recycling is controlled by the operator to prevent interference with prompt and sanitary operations and is conducted to prevent a health hazard or nuisance.
(c) Salvaged materials shall be promptly moved from the unloading area and stored in an approved area under Chapter 285 (relating to storage, collection and transportation of municipal waste) or transported offsite.
Subchapter D. ADDITIONAL APPLICATION REQUIREMENTS FOR SPECIAL HANDLING WASTES § 283.302. (Reserved).
Subchapter E. ADDITIONAL OPERATING REQUIREMENTS FOR SPECIAL HANDLING WASTES § 283.402. (Reserved).
CHAPTER 284. INFECTIOUS AND CHEMOTHERAPEUTIC WASTE Subch.
A. GENERAL PROVISIONS
B. GENERAL PERMITS
C. TRANSFER FACILITIES
D. PROCESSING FACILITIES
E. STORAGE
F. COLLECTION AND TRANSPORTATION
G. TRANSPORER LICENSING FOR INFECTIOUS AND CHEMOTHERAPEUTIC WASTE
H. MANIFESTING FOR INFECTIOUS AND CHEMOTHERA-PEUTIC WASTE
Subchapter A. GENERAL PROVISIONS
GENERAL PROVISIONS Sec.
284.1. Scope.
284.2. Permit by rule for infectious or chemotherapeutic waste pro-cessing facilities; qualifying facilities; general requirements.
GENERAL PROVISIONS § 284.1. Scope.
This chapter sets forth application and operating requirements for a person or municipality that operates an infectious or chemotherapeutic waste facility. The requirements in this chapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management--general provisions).
§ 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; and infectious and chemotherapeutic 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 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).
(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.
Subchapter B. GENERAL PERMITS Sec.
GENERAL 284.101. Authorization for general permits.
284.102. Nature of a general permit; substitution for individual applications.
ISSUANCE OF A GENERAL PERMIT 284.111. Application for general permit.
284.112. Completeness review.
284.113. Public notice and review period.
284.114. Approval or denial of an application.
284.115. Department-initiated general permits.
CONTENT OF GENERAL PERMITS AND WAIVERS 284.121. Contents of general permits.
284.122. Waiver or modification of certain requirements.
REGISTRATION AND DETERMINATION OF APPLICABILITY 284.131. Authorization for persons or municipalities to be included in a general permit.
284.132. Determination of applicability.
284.133. Registration.
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 infectious 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 (relating to issuance of a general permit).
(c) The Department may issue a general permit for the mixing of disinfection products with infectious 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 infectious 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 infectious 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 an infectious or chemotherapeutic waste processing facility on either a regional or Statewide basis, persons or municipalities who intend to process infectious 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 § 284.132 or § 284.133 (relating to determination of applicability; and 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 when the person or municipality is not in compliance with the conditions of the 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 infectious or chemotherapeutic waste.
(b) An application for the issuance of a general permit for processing infectious 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 infectious 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 infectious 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 infectious or chemotherapeutic waste, limiting the number of persons handling the waste and minimizing the possibility of exposure of that waste to employes and the public using or visiting the facility.
(v) A description of the method proposed for disinfecting emptied, reusable infectious waste containers, transport vehicles and facility equipment which are known or suspected to be contaminated with infectious waste.
(vi) A description of the method proposed for handling and disposal of infectious 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 employes against exposure to infectious 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 infectious 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 infectious 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 infectious 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 infectious 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 infectious 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 infectious 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 infectious 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 infectious waste to perform processing.
§ 284.112. Completeness review.
(a) After receipt of an application for the issuance of a general permit, or an application for a determination of applicability under § 284.132 (relating to determination of applicability), 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 or the determination of applicability.
(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 infectious 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 overriden 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 infectious 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 infectious 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) shall include the following:
(1) A clear and specific description of the category of processing of infectious 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 Departmental 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.
CONTENT OF GENERAL PERMITS AND WAIVERS § 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 infectious 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 or determination of applicability 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 or applicants 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 manifest, in accordance with Subchapter H (relating to manifesting), when appropriate.
(9) A requirement that waste be delivered by a licensed transporter in accordance with Subchapter G (relating to transporter licensing), 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 disposed of in a landfill that has obtained written approval by the Department to dispose of the waste.
(12) A requirement that an up-to-date list of names, addresses and telephone numbers of employes 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 employe 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 requirement that autoclaves meet the following:
(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.
§ 284.122. Waiver or modification of certain requirements.
(a) An operation that is approved under this subchapter does not require an individual processing or disposal permit under this article.
(b) For an operation that is approved under this subchapter, the Department may waive or modify any application and operating requirements in this article, except the Department may not waive § 271.123 and may not waive or modify Chapter 271, Subchapter A, §§ 271.124, 271.125, 271.129 and Subchapter E.
REGISTRATION AND DETERMINATION OF APPLICABILITY § 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 one of the following occurs:
(1) If the applicable general permit requires persons or municipalities to register with the Department prior to operating under the general permit, the person or municipality has registered in accordance with the terms of the general permit and the requirements of this subchapter.
(2) If the applicable general permit requires persons or municipalities to apply for and obtain a determination of applicability from the Department prior to operating under the general permit, and the Department has made this determination.
(b) Registration or application requirements and time limits, if any, shall be set forth in the general permit governing each category of processing infectious or chemotherapeutic waste. The general permit shall also set forth the area or region within which each category of processing is allowed.
(c) At a minimum, the registration or application for determination of applicability shall 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 infectious 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 infectious or chemotherapeutic waste under the general permit.
(d) A person or municipality that registers for coverage under a general permit or applies to the Department for a determination of applicability of a general permit shall submit a copy of the registration or application 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 or application with the Department.
§ 284.132. Determination of applicability.
If a general permit specifies that potential users of the permit shall obtain a determination of applicability from the Department prior to conducting the activity authorized by the general permit, the procedures in this section shall be followed in addition to those stated in § 284.131 (relating to authorization for persons or municipalities to be included in a general permit):
(1) An application for a determination of applicability shall be accompanied by a nonrefundable fee in the form of a check payable to the ''Commonwealth of Pennsylvania'' for $500.
(2) The Department will provide notice in the Pennsylvania Bulletin of each application for a determination of applicability for a general permit which the Department has determined to be administratively complete. The Department may indicate in the notice that interested persons or municipalities may submit comments to the Department within a 60-day period. If a comment period is provided, counties may recommend to the Department conditions, revisions or disapproval of the application. The Department may hold a public meeting or public hearing on an application for determination of applicability for a general permit.
(3) The Department will make a determination that a general permit is or is not applicable to an activity for which an application for determination of applicability is filed within 60 days from the publication of the notice under paragraph (2) or, if a comment period is provided, within 120 days after publication of the notice. The time period does not include periods beginning with the date the Department has requested in writing that the applicant make substantive corrections or changes to the application and ending with the date that the applicant submits corrections or changes to the Department's satisfaction. Failure by the Department to comply with this timetable will not be construed or understood to constitute grounds for a determination that the general permit applies to the proposed activity.
(4) The Department will determine that the general permit does not apply to the proposed processing activity and deny coverage under the general permit if the applicant fails to demonstrate the following to the Department's satisfaction:
(i) That the proposed activity is consistent with the terms and conditions of the general permit.
(ii) That the activity does not have the potential to harm or present a threat of harm to the health, safety or welfare of the people or the environment of this Commonwealth.
(5) The Department will publish notice of its decision regarding each determination of applicability in the Pennsylvania Bulletin. If a county has made recommendations to the Department concerning conditions, revisions or disapproval of the permit during a 60-day comment period, and the Department has overriden the recommendations, the Department will publish its justification for overriding the recommendations in the Pennsylvania Bulletin. The applicant for a determination of applicability for coverage under a general permit shall provide written notice to each municipality in which the applicant intends to operate pursuant to the general permit.
(6) The Department may amend, suspend or revoke coverage under a general permit if the waste or the activity is not consistent with the terms and conditions of the general permit.
§ 284.133. Registration.
(a) When a general permit specifies that potential users are required to register with the Department prior to operating under the general permit, the procedures in this section shall be followed in addition to those in § 284.131 (relating to authorization for persons or municipalities to be included in a general permit).
(1) A registration to operate under a general permit shall be accompanied by a nonrefundable fee in the form of a check payable to the ''Commonwealth of Pennsylvania'' for $250.
(2) The Department will publish notice of each registration to operate under a general permit in the Pennsylvania Bulletin. The registrant under a general permit shall provide written notice to each municipality in which the registrant intends to operate under the general permit.
(b) Persons or municipalities may conditionally operate under a general permit in accordance with the terms of the general permit immediately upon registering with the Department.
(c) Upon the request of the Department, a person or municipality shall provide sufficient information to demonstrate to the satisfaction of the Department that the person or municipality is authorized to operate under the general permit. The Department may refuse to issue or approve a registration if the person or municipality has failed to demonstrate that the person or municipality is in conformance with the general permit.
(d) The Department may amend, suspend or revoke registration under a general permit if the waste or the activity is not consistent with the terms and conditions of the general permit.
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