[30 Pa.B. 6685]
[Continued from previous Web Page]
Subchapter C. TRANSFER FACILITIES Sec.
284.201. Scope.
284.210. Application requirements.
284.220. Operating requirements.
§ 284.201. Scope.
This subchapter sets forth application and operating requirements for a person or municipality that operates a transfer facility for infectious or chemotherapeutic waste. The requirements in this subchapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management--general).
§ 284.210. Application requirements.
An application to operate a transfer facility shall comply with §§ 279.101--279.111 (relating to general requirements).
§ 284.220. Operating requirements.
A person or municipality that operates a transfer facility shall comply with §§ 279.201--279.262.
Subchapter D. PROCESSING FACILITIES Sec.
284.301. Scope.
284.310. Application requirements.
284.311. Plan for monitoring.
284.320. Operating requirements.
284.321. Infectious waste monitoring requirements.
§ 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 infectious 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).
§ 284.310. Application requirements.
An application to operate a processing facility shall comply with §§ 283.101--283.114 (relating to general provisions).
§ 284.311. Plan for monitoring.
An application for a processing facility for infectious 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 infectious 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 §§ 283.201--283.224, 283.231--283.262 and 283.271--283.272.
§ 284.321. Infectious waste monitoring requirements.
(a) A person or municipality that disinfects infectious waste shall monitor the waste to ensure the following:
(1) For thermal processing or incineration, the absence of anaerobic or aerobic bacterial growth in a composite sample of processing residue or ash.
(2) For other disinfection processes, both of the following are met:
(i) The process shall be capable of inactivating vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites and mycobacteria at a 6 log 10 reduction or greater.
(ii) Inactivating stearothermophilus spores, B. pumilus or B. subtilis spores at a 4 log 10 reduction or greater.
(b) The operator of a facility that incinerates or thermally processes infectious waste shall submit to the Department a microbiological analysis of a composite sample of the processing or ash residue on forms provided by the Department at a minimum, quarterly during the life of the facility.
(c) The operator of a facility that incinerates infectious waste shall submit to the Department, at least annually during the life of the facility, a chemical analysis of composite samples of the ash residue on forms provided by the Department.
(d) If the facility disinfects infectious waste by means other than incineration or thermal processing, the operator shall perform a microbiological analysis of indicators removed from the processed waste. The analysis shall be conducted at a minimum, every 40 hours during the operational life of the facility, unless otherwise provided in a permit. The analyses shall be made available to the Department upon request.
(e) Unless the Department approves another indicator or test in writing, the following indicators shall be used to establish and verify the following processes:
(1) For autoclaving, spores of Bacillus stearothermo- philus.
(2) For dry heat, gas or chemical disinfection, spores of Bacillus subtilis variety niger (globigii). Ethylene oxide may not be used for gas disinfection.
(3) For ionizing radiation, spores of Bacillus pumilus.
(f) Indicators used for methods of disinfection other than incineration or thermal processing shall be located prior to disinfection at a point where disinfection will be most difficult to achieve.
(g) Infectious waste will be considered to be infectious after disinfection, unless one of the following has occurred:
(1) For disinfection processes other than incineration or thermal processing, the indicator spores are determined by microbiological analysis to have been destroyed in accordance with subsection (a).
(2) For incineration or thermal processing using a test other than an indicator spore, a microbiological analysis determines that disinfection has occurred in accordance with subsection (a).
(h) The operator of the disinfection facility shall so certify that the requirements of subsection (a) have been met on a form provided by the Department.
(i) Ash or other processing residue shall be stored in accordance with § 284.418 or § 284.419 (relating to storage and containment of ash residue from infectious or chemotherapeutic waste incineration; and storage and containment of processing residue from an infectious or chemotherapeutic waste facility).
(j) Ash or other processing residue shall be transported in accordance with § 284.511 or § 284.514 (relating to transportation of ash residue from infectious or chemotherapeutic waste incineration; and transportation of processing residue from an infectious or chemotherapeutic waste facility).
(k) Compactors, grinders or similar devices may not be used to reduce the volume of infectious waste before the waste has been rendered noninfectious. If the volume reduction device is within a continuous, enclosed disinfection process and part of one processing system, then the reduction device may be used.
(l) The operator of an infectious waste processing facility shall dispose of ash or other processing residue from the facility in a landfill that has been approved by the Department to accept the waste, if the waste is disposed in this Commonwealth.
(m) In addition to other applicable requirements, an autoclave facility shall comply with the following:
(1) The processing of pathological waste is prohibited.
(2) The facility shall maintain a retention time for processing bulk fluids (greater than 500 ml) which allows for the complete vaporization of fluids.
Subchapter E. STORAGE Sec.
284.401. Scope.
284.411. Basic storage requirements.
284.412. Sorting.
284.413.
Duration of storage of infectious waste for generators.
284.414. Duration of storage of infectious waste for processors.
284.415. Storage containers.
284.416. Marking of containers.
284.417. Reuse of containers.
284.418. Storage and containment of ash residue from infectious or chemotherapeutic waste incineration.
284.419. Storage and containment of processing residue from an infectious or chemotherapeutic waste processing facility.
§ 284.401. Scope.
This subchapter sets forth operating requirements for a person or municipality that stores infectious or chemotherapeutic waste, ash residue from infectious or chemotherapeutic waste incineration and processing residue from an infectious or chemotherapeutic waste processing facility. The requirements in this chapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management--general provisions) and the requirements in §§ 285.111--285.121 (relating to general provisions and types of storage).
§ 284.411. Basic storage requirements.
(a) Infectious and chemotherapeutic waste shall be stored and contained in a manner that:
(1) Maintains the integrity of the containers, prevents the leakage or release of waste from the containers and provides protection from water, rain and wind.
(2) Prevents the spread of infectious or chemotherapeutic agents.
(3) Affords protection from animals and does not provide a breeding place or a food source for insects or rodents.
(4) Maintains the waste in a nonputrescent state, using refrigeration (<=7°C) or freezing (-18°C) when necessary.
(5) Prevents odors from emanating from the container.
(6) Prevents unauthorized access to the waste. As part of this requirement, the following shall be met:
(i) Enclosures and containers used for storage of infectious or chemotherapeutic waste shall be secured to deny access to unauthorized persons.
(ii) Enclosures and containers shall also be marked with prominent warning signs indicating the storage of infectious or chemotherapeutic waste.
(b) Enclosures at a waste generating or processing facility that are used for the storage of infectious or chemotherapeutic waste shall be constructed of finish materials that are impermeable and capable of being readily maintained in a sanitary condition. Storage areas shall be ventilated to minimize human exposure to the exhaust air.
(c) Infectious and chemotherapeutic waste may not be commingled with other waste.
(d) The generator may store infectious and municipal waste that has been sorted and separately containerized on the same cart for movement to an onsite processing or disposal facility. Chemotherapeutic waste may also be stored on the cart with municipal and infectious waste if it is sorted and separately containerized and if it is moved to an onsite incinerator.
§ 284.412. Sorting.
(a) Infectious and chemotherapeutic waste shall be placed in separate containers from other waste at the point of orgin in the generating facility.
(b) Infectious and chemotherapeutic waste may be stored together in the same container if approved in writing by the Department.
(c) Used sharps, regardless of whether they are infectious or chemotherapeutic waste, may be stored in the same container if the requirements of §§ 284.413(a) and 284.415(a) and (b) (relating to duration of storage of infectious waste for generators; and storage containers) are met.
(d) Infectious waste shall be sorted at the point of origin in the generating facility into the following three classes, and each class shall be placed in a separate containter:
(1) Used sharps.
(2) Fluids--quantities greater than 20 cubic centimeters.
(3) Other infectious waste.
(e) Chemotherapeutic waste shall be sorted at the point of origin in the generating facility into the following three classes, and each class shall be placed in a separate container:
(1) Used sharps.
(2) Fluids.
(3) Other chemotherapeutic waste.
(f) Sorted and separately containerization infectious waste may be placed together into another container for onsite handling or offsite transportation.
§ 284.413. Duration of storage of infectious waste for generators.
(a) Generators that store infectious or chemotherapeutic waste onsite shall meet the following requirements:
(1) Infectious waste, excluding used sharps, may be stored at room temperature until the storage container is full, but for no longer than 30 days from the date waste was first placed in the container.
(2) A storage container filled with infectious waste may be stored in a refrigeration unit for up to 30 days from the date waste was first placed in the container.
(3) A storage container of infectious waste that has been filled within 30 days from the date waste was first placed in the container may be frozen immediately for up to 90 days from the date waste was first placed in the container.
(b) If the infectious waste becomes putrescent during the storage period identified in subsection (a), the waste shall be moved offsite within 24 hours for processing or disposal.
(c) Used sharps containers may be used until full as long as the storage is in accordance with § 284.411 (relating to basic storage requirements).
§ 284.414. Duration of storage of infectious waste for processors.
If the waste processing facility is separate from the waste generating facility, infectious waste may not be stored at the waste processing facility for more than the following periods unless other periods are approved in a permit:
(1) Seventy-two hours at a temperature <=28°C.
(2) Seven days in a refrigerator at <=7°C.
(3) Thirty days in a freezer at -18°C.
§ 284.415. Storage containers.
(a) Infectious and chemotherapeutic waste shall be placed in containers that are:
(1) Leakproof.
(2) Impervious to moisture.
(3) Sufficient in strength to prevent puncturing, tearing or bursting during storage.
(b) In addition to the requirements of subsection (a), used sharps shall be stored in containers that are:
(1) Rigid.
(2) Tightly lidded.
(3) Puncture resistant.
(c) In addition to the requirements of subsection (a), infectious waste fluids--quantities greater than 20 cubic centimeters--and chemotherapeutic waste fluids shall be stored in containers that are:
(1) Break resistant.
(2) Tightly lidded or tightly stoppered.
(d) When bags are used as the only storage container, double or multiple bagging shall be employed and the following requirements shall be met:
(1) Upon packaging, the bags shall be securely tied.
(2) The bag shall be constructed of material of sufficient single thickness strength to meet the following:
(i) The ASTM standard D1709-91, Test Method for Impact Resistance of Polyethylene Film by the Free Falling Dart Method, with an impact resistance of 165 grams or greater (Method A).
(ii) The ASTM standard D1922-89, Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method, with a tearing resistance, parallel and perpendicular to the length of the bag, of 480 grams.
(iii) If the standards in subparagraphs (i) and (ii) are modified by ASTM, the standard that is in effect on the date of manufacture of the bags shall be applied.
(3) Bags shall include one of the following certifications indicating that the ASTM standards have been met:
(i) Each bag shall contain a printed certification by the manufacturer.
(ii) The manufacturer may issue a certification letter to the infectious or chemotherapeutic waste generator and print a certification on each packaged lot of the bags.
(4) Bags used as containers shall have sufficient seam strength that is at least equal in resistance to tearing and equally impermeable as the other portions of the bag.
(5) Bags used as containers shall be yellow in color for each package of chemotherapeutic waste and fluorescent orange, orange-red or red in color for each package of infectious waste and shall be labeled in accordance with § 284.416(c) (relating to marking of containers).
(e) Fluorescent orange, orange-red or red or yellow containers shall contain colorants which are organic pigments with no heavy metal content.
(f) With the exception of persons who work at a small quantity generator's operation, where less than 220 pounds of infectious and chemotherapeutic waste is generated per month, persons packaging infectious or chemotherapeutic waste for offsite transportation shall wear:
(1) Protective overalls.
(2) Heavy gloves of neoprene or equivalent materials.
§ 284.416. Marking of containers.
(a) The outermost container for each package of infectious or chemotherapeutic waste for offsite transportation shall be labeled immediately after packing. The label shall be securely attached and shall be clearly legible. Indelible ink shall be used to complete the information on the label. If handwritten, the label shall be at least 3 inches by 5 inches in dimension.
(b) The following information shall be included on the label:
(1) The name, address and telephone number of the generator.
(2) The date the waste was generated.
(3) The name of the transporter and, if applicable, Department-issued infectious and chemotherapeutic waste transporter license number.
(c) The following information shall be printed on the outermost container or bag for each package of infectious or chemotherapeutic waste for either onsite movement or offsite transportation:
(1) The words ''infectious waste'' or ''chemotherapeutic waste,'' whichever is applicable.
(2) The universal biohazard symbol that conforms to the design shown in regulations of the United States Occupational Safety and Health Administration at 29 CFR 1910.145(f)(8)(ii) (relating to specifications for accident prevention signs and tags).
(d) The color coding scheme for infectious and chemotherapeutic waste bags and nonwall-mounted used sharps containers shall be fluorescent orange, orange-red or red in color, or predominately so, for infectious waste and yellow in color, or predominately so, for chemotherapeutic waste, with lettering and symbols in a contrasting color (for example, black).
(e) Stationary waste storage containers shall be lined with the appropriate colored bag for infectious or chemotherapeutic waste.
§ 284.417. Reuse of containers.
(a) Nonrigid containers shall be managed as either infectious or chemotherapeutic waste, based upon the contents of the container. These containers may not be reused.
(b) Corrugated fiberboard containers used for storage of infectious or chemotherapeutic waste may be reused if the surface of the container has been protected from direct contact with the waste.
(c) A rigid, nonfiberboard container used for the storage of infectious waste may be reused if one of the following applies:
(1) The container has been decontaminated utilizing a Department-approved decontamination procedure.
(2) The surface of the container has been protected from direct contact with infectious waste.
(d) A rigid container used for the storage of chemotherapeutic waste may be reused if the surface of the container has been protected from direct contact with chemotherapeutic waste.
§ 284.418. Storage and containment of ash residue from infectious or chemotherapeutic waste incineration.
(a) Ash residue from infectious or chemotherapeutic waste incineration shall be stored in accordance with the following:
(1) In an enclosed container, which may include a properly tarped container, or in an enclosed area, which may include an adequately ventilated building.
(2) On a pad that is no more permeable than 1 x 10-7 cm./sec.
(3) To prevent the release, dispersal or discharge of ash residue into the air, water or onto land.
(b) Ash residue may be commingled with other municipal waste if the commingled waste is from one generator and if storage of the commingled waste is in accordance with subsection (a).
§ 284.419. Storage and containment of processing residue from an infectious or chemotherapeutic waste processing facility.
(a) Processing residue from infectious or chemotherapeutic waste processing facilities shall be stored in an enclosed container, which may include a properly tarped container, or in an enclosed area, which may include an adequately ventilated building, in order to:
(1) Prevent the release, dispersal or discharge of processing residue into the air, water or onto land.
(2) Afford protection from animals, rain and wind.
(3) Prevent the development of a breeding place or food source for insects or rodents.
(4) Prevent the leakage of waste from the storage container.
(b) Processing residue from an infectious or chemotherapeutic waste processing facility may be commingled with other municipal waste if the commingled waste is from one generator and if storage of the commingled waste is in accordance with subsection (a).
Subchapter F. COLLECTION AND TRANSPORTATION
GENERAL Sec.
284.501. Scope.
TYPES OF WASTE 284.511. Transportation of ash residue from infectious or chemotherapeutic waste incineration.
284.512. Transportation of infectious and chemotherapeutic waste; general provisions.
284.513. Transportation of infectious and chemotherapeutic waste; additional provisions.
284.514. Transportation of processing residue from an infectious or chemotherapeutic waste facility.
GENERAL § 284.501. Scope.
This subchapter sets forth the requirements for a person or municipality that collects and transports infectious or chemotherapeutic waste, ash residue from infectious or chemotherapeutic waste incineration and processing residue from an infectious or chemotherapeutic waste processing facility. The requirements in this chapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management--general provisions) and the requirements in §§ 285.211--285.219 (relating to general provisions).
TYPES OF WASTE § 284.511. Transportation of ash residue from infectious or chemotherapeutic waste incineration.
(a) Ash residue from infectious or chemotherapeutic waste incineration shall be wetted immediately prior to loading, and shall remain wetted during transportation and unloading at a municipal waste landfill, to prevent the dispersal of ash residue.
(b) Ash residue from infectious or chemotherapeutic waste incineration shall be transported in an enclosed or covered vehicle to prevent dispersal of the residue.
(c) A transporter shall transport separately each generator's ash residue from infectious or chemotherapeutic waste.
(d) A transporter may transport ash residue from an infectious or chemotherapeutic waste incinerator that is commingled with other municipal waste if the commingled waste is from one generator and the waste is transported separately from another generator's waste.
§ 284.512. Transportation of infectious and chemotherapeutic waste; general provisions.
(a) General. This section sets forth general requirements for a person or municipality that transports infectious or chemotherapeutic waste. Section 284.513 (relating to transportation of infectious and chemotherapeutic waste; additional provisions) sets forth additional provisions relating to the transportation of the waste.
(b) Manner of transportation. Infectious and chemotherapeutic waste shall be transported in a manner that:
(1) Maintains the integrity of the containers, prevents the leakage or release of waste from the containers and provides protection from water, rain and wind.
(2) Prevents the spread of infectious or chemotherapeutic agents.
(3) Affords protection from animals and does not provide a breeding place or a food source for insects or rodents.
(4) Maintains the waste in a nonputrescent state, using refrigeration (<=7°C) or freezing (-18°C) when necessary.
(5) Prevents odors from emanating from the container.
(6) Prevents unauthorized access to the waste.
(c) Containers.
(1) Infectious and chemotherapeutic waste shall be transported in containers that are:
(i) Rigid.
(ii) Leakproof.
(iii) Impervious to moisture.
(iv) Sufficient in strength to prevent puncturing, tearing or bursting during transportation. A single-walled, corrugated fiberboard container shall be of a classified strength of at least 200 pounds per square inch, with a gross weight limit of at least 65 pounds at the time the container is manufactured. Compliance with these requirements shall be certified on the container by the manufacturer.
(2) In addition to the requirements of paragraph (1), used sharps shall be transported in containers that are tightly lidded.
(3) In addition to the requirement of paragraph (1), infectious waste fluids--quantities greater than 20 cubic centimeters--and chemotherapeutic waste fluids shall be transported in containers that are:
(i) Break resistant.
(ii) Tightly lidded or tightly stoppered.
(4) Bags meeting the requirements of § 284.415 (relating to storage containers) may be used to meet the requirements of this subsection that containers be leakproof and impervious to moisture.
(d) Infectious and chemotherapeutic waste may not be transported in the same containers, unless approved in writing by the Department. Infectious and chemotherapeutic waste shall be transported in separate vehicles from those used for other waste.
(e) Vehicles for transporting infectious or chemotherapeutic waste shall be noncompaction type vehicles.
(f) Load compartments of vehicles holding infectious or chemotherapeutic waste for transportation shall be constructed of materials that are impermeable and easily cleaned. Surfaces of vehicles that have been in direct physical contact with infectious or chemotherapeutic waste, because of a leak in the bag or container or because of another reason, shall be decontaminated as soon as possible after unloading.
(g) Infectious waste may not be kept in an unrefrigerated transport vehicle for more than 48 hours. If the vehicle is refrigerated (<=7°C) or maintained at freezing temperatures (-18°C), the in-transit storage period may not exceed 5 days.
(h) Chutes may not be used by generators, processors or transporters to transfer infectious or chemotherapeutic waste at onsite or offsite locations.
§ 284.513. Transportation of infectious and chemotherapeutic waste; additional provisions.
(a) This section sets forth additional requirements for the transportation of infectious and chemotherapeutic waste. This section does not apply to vehicles used by a generator of less than 220 pounds of infectious and chemotherapeutic waste per month for transporting waste that he generated.
(b) Vehicles for transporting infectious or chemotherapeutic waste shall be identified on the two sides and back of the cargo compartment with the following:
(1) The transporter's Department-issued infectious and chemotherapeutic waste license number, if applicable.
(2) A placard or decal containing the phrase ''infectious waste'' or ''chemotherapeutic waste,'' or both, and the universal biohazard symbol that conforms to the design shown in the United States Occupational Safety and Health Administration's regulations at 29 CFR 1910.145 (f)(8)(ii) (relating to specifications for accident prevention signs and tags). The placard or decal shall be capable of being read at a distance of 25 feet.
(c) A vehicle used for transporting infectious or chemotherapeutic waste shall contain, in a readily accessible place, a portable decontamination and spill containment unit, including at a minimum the following:
(1) An adequate amount of absorbent material.
(2) One gallon of hospital grade disinfectant in an appropriate applicator.
(3) Fifty fluorescent orange, orange-red or red or yellow, or both, plastic bags that meet the requirements of § 284.415 (relating to storage containers). The bags shall be accompanied by seals and appropriate labels, and shall be large enough to overpack any container normally transported in the vehicle.
(4) Two sets of protective overalls, gloves, boots, caps, goggles and masks. The protective garments shall be oversized or fitted for the vehicle operators.
(5) A first aid kit, boundary marking tape and other appropriate safety equipment.
(d) The surface of vehicles that have not been in direct physical contact with infectious or chemotherapeutic waste shall be cleaned weekly. Drainage from the cleaning shall be discharged directly or through a holding tank to a sanitary sewer system or treatment facility.
(e) Individuals loading or unloading containers of infectious or chemotherapeutic waste onto or off transportation vehicles shall wear protective overalls and heavy gloves of neoprene or equivalent materials. Gloves and coveralls shall be decontaminated after each loading or unloading operation if the gloves and coveralls have been contaminated or are suspected of having been contaminated. If no contamination occurs or none is suspected, decontamination shall be completed at the end of the working day or work shift.
§ 284.514. Transportation of processing residue from an infectious or chemotherapeutic waste facility.
(a) Processing residue from an infectious or chemotherapeutic waste facility shall be transported in an enclosed or covered vehicle to prevent dispersal of the residue.
(b) A transporter shall transport separately each generator's processing residue from infectious or chemotherapeutic waste.
(c) A transporter may transport processing residue from infectious or chemotherapeutic waste that is commingled with other municipal waste if the commingled waste is from one generator and the waste is transported separately from another generator's waste.
Subchapter G. TRANSPORTER LICENSING FOR INFECTIOUS AND CHEMOTHERAPEUTIC WASTE
GENERAL PROVISIONS Sec.
284.601. Scope.
284.602. License requirement.
284.603. Identification number.
LICENSE APPLICATION REQUIREMENTS 284.611. General application requirements.
284.612. Vehicular liability insurance.
LICENSE APPLICATION REVIEW 284.621. Criteria for license issuance or denial
284.622. Term of license.
284.623. Conditions of licenses.
284.624. License renewal.
284.625. Public notice.
OPERATIONAL REQUIREMENTS 284.631. Basic limitations.
284.632. Infectious or chemotherapeutic waste discharges or spills.
284.633. Safety.
284.634. Annual report.
BOND 284.641. Bond requirements.
284.642. Release of bond.
284.643. Bond forfeiture.
284.644. Replacement of existing bond.
284.645. Preservation of remedies.
GENERAL PROVISIONS § 284.601. Scope.
This subchapter sets forth the Department's requirements for licensing of persons and municipalities that transport infectious or chemotherapeutic waste.
§ 284.602. License requirement.
(a) Except as provided in subsection (b), a person or municipality may not transport infectious or chemotherapeutic waste unless the person has first obtained a license from the Department in accordance with this subchapter.
(b) This subchapter does not apply to the following:
(1) Onsite movement of infectious or chemotherapeutic waste by generators.
(2) Onside movement of infectious or chemotherapeutic waste by owners or operators of permitted infectious or chemotherapeutic waste management facilities.
(3) Transportation by a generator of less than 220 pounds per month of infectious or chemotherapeutic waste when transporting only the infectious or chemotherapeutic waste he generated if the manifesting requirements under § 284.701(b)(3) (relating to scope) are met.
(4) The transportation of infectious or chemotherapeutic waste generated outside this Commonwealth destined for processing or disposal outside this Commonwealth.
§ 284.603. Identification number.
A person or municipality subject to this chapter may not transport infectious or chemotherapeutic waste without first receiving an identification number. The number shall be one of the following:
(1) An EPA identification number obtained under section 3010 of the Resource Conservation and Recovery Act of 1976 (42 U.S.C.A. § 6930).
(2) An identification number obtained from the Department, if the identification number under paragraph (1) is not available.
LICENSE APPLICATION REQUIREMENTS § 284.611. General application requirements.
(a) An application for a license to transport infectious or chemotherapeutic waste shall be submitted to the Department, in writing, on forms provided by the Department. An application for a license shall be accompanied by information, specifications and other data required by the Department to determine compliance with this subchapter.
(b) The application shall contain the following:
(1) The applicant's identification number, as required by § 284.603 (relating to identification number).
(2) The name, mailing address, place of business, business telephone number and 24-hour emergency telephone number of the applicant.
(3) The average yearly total tonnage of infectious and chemotherapeutic waste picked up or delivered in this Commonwealth.
(4) A nonrefundable application fee in the form of a check payable to the ''Commonwealth of Pennsylvania'' for $500.
(5) Information concerning terminal locations that will store infectious and chemotherapeutic waste in-transit.
(6) An identification of interests and compliance history, as provided in §§ 271.124 and 271.125 (relating to identification of interests; and compliance information).
(7) Collateral bond, as required by § 284.641 (relating to bond requirement).
(8) Certificate of insurance, as required by § 284.612 (relating to vehicular liability insurance).
(9) A contingency plan consistent with § 284.632 (relating to infectious or chemotherapeutic waste discharges or spills).
(c) An application for a license shall be certified by a responsible official of the applicant with a statement that the information contained in the application is true and correct to the best of the official's information and belief.
§ 284.612. Vehicular liability insurance.
(a) The application shall include a certificate of insurance issued by an insurance company authorized to do business in this Commonwealth, certifying that the applicant has comprehensive vehicular liability insurance in force covering the operation of vehicles and associated infectious and chemotherapeutic waste transportation activities.
(b) The certificate of insurance shall expressly document coverage for property damage and bodily injury to third parties. The insurance coverage shall include coverage for the cost of cleaning up an infectious or chemotherapeutic waste spill, and damages arising from the spill. Minimum insurance coverage shall be $500,000 annual aggregate, exclusive of claims administration and legal defense costs.
(c) Insurance coverage provided under this section shall comply with the following:
(1) The insurance policy shall follow the standard commercial or comprehensive vehicular liability policy forms approved by the Insurance Department, and shall include coverage as specified in subsections (a) and (b).
(2) The insurance policy shall be issued by an insurer having a certificate of authority and a licensed agent authorized to transact the business of insurance in this Commonwealth by the Insurance Department. Insurance may be provided by an excess or surplus lines insurer approved by the Insurance Department.
(3) The full policy amount shall be applicable to each driver and vehicle authorized to operate under the license. There may be no proration of the policy amount of coverage among vehicles.
(4) The insurance policy shall provide that the insurer shall notify the Department by certified mail within 30 days whenever a substantive change is made in the policy, including policy amounts, scope of coverage, tail period, claims procedures, definitions of occurrences or claims or other provisions related to the requirements of this subchapter.
(d) The licensee shall maintain the insurance required by this section in full force and effect during the term of the license and renewals thereof.
(e) An applicant for a transporter license to transport infectious or chemotherapeutic waste which is a department or an agency of the United States or of the Commonwealth may fulfill the requirements under this section by means of one or more of the following:
(1) Commercial insurance as specified in this section.
(2) Self-insurance allowed by Federal or State law.
(3) Additional means approved by the Department.
(f) The amount of liability coverage for departments or agencies of the Commonwealth may not exceed the liability limits of 42 Pa.C.S. Chapter 85 (relating to matters affecting government units).
LICENSE APPLICATION REVIEW § 284.621. Criteria for license issuance or denial.
(a) A license application will not be approved unless the applicant affirmatively demonstrates to the Department's satisfaction that the following conditions are met:
(1) The license application is complete and accurate.
(2) The requirements of the act, the environmental protection acts and this title have been complied with.
(3) The compliance status of the applicant or a related party under section 503(c) and (d) of the act (35 P. S. § 6018.503(c) and (d)) does not require or allow license denial.
(b) The Department will deny a license application if the applicant fails to provide the Department with a bond consistent with this subchapter or fails to provide other required information within 120 days after the Department's written request.
§ 284.622. Term of license.
A license granted or renewed under this subchapter is valid for 2 years unless the Department determines that circumstances justify issuing a license for less than 2 years. The expiration date will be set forth in the license.
§ 284.623. Conditions of licenses.
(a) The Department may place terms and conditions upon a license it deems necessary to protect public health, public safety and the environment, and to ensure compliance with the act, the environmental protection acts and this title.
(b) Except to the extent that the license states otherwise, the licensee shall conduct transportation activities as described in the approved application.
(c) A license to transport infectious and chemotherapeutic waste is nontransferable and nonassignable. A license applies to the licensee and its employes. Leased or subcontracted drivers, and drivers who provide equipment, have no authority to operate under the licensee's license without prior written approval from the Department.
§ 284.624. License renewal.
A licensee that plans to transport infectious or chemotherapeutic waste after expiration of the current license term under § 284.622 (relating to term of license) shall file a complete application for license renewal on forms provided by the Department at least 90 days before the expiration date of the license. The application shall include a nonrefundable application fee in the form of a check payable to the ''Commonwealth of Pennsylvania'' for $500. The license renewal application will be reviewed by the Department in the same manner as a new application for a license under this subchapter.
§ 284.625. Public notice.
The Department will publish notice in the Pennsylvania Bulletin of the following:
(1) Receipt of an application for a license under this subchapter.
(2) Approval or denial of a license application under this subchapter.
OPERATIONAL REQUIREMENTS § 284.631. Basic limitations.
(a) A person or municipality subject to this subchapter that transports infectious or chemotherapeutic waste shall comply with the following:
(1) The act, this article and other applicable regulations promulgated under the act, including Subchapter F (relating to collection and transportation).
(2) The terms and conditions of the license, the environmental protection acts, this title and orders issued by the Department.
(b) A transporter shall allow authorized representatives of the Commonwealth, without advance notice or a search warrant, upon presentation of appropriate credentials, and without delay, to have access to areas in which operations will be, are being or have been conducted.
§ 284.632. Infectious or chemotherapeutic waste discharges or spills.
(a) A copy of the most recently approved Transporter Contingency Plan (TCP) shall be carried on each transport vehicle at all times. Information in the TCP shall be kept current.
(b) In the event of a discharge or spill of infectious or chemotherapeutic waste during transportation, the transporter shall take appropriate immediate action to protect the health and safety of the public and the environment, in accordance with its approved TCP. The transporter shall also immediately telephone the Department and the affected municipality, and provide the following information:
(1) The name of the person reporting the spill or discharge.
(2) The transporter's name, address, the Department-issued infectious and chemotherapeutic waste transporter license number and identification number.
(3) The telephone number where the person reporting the spill or discharge can be reached.
(4) The date, time and location of the spill or discharge.
(5) The mode of transportation and type of transport vehicle.
(6) A brief description of the accident.
(7) For each waste involved in the spill:
(i) The name and identification number of the generators of the waste.
(ii) The estimated quantity of the waste spilled.
(c) If a discharge or spill of infectious or chemotherapeutic waste occurs during transportation, and if the immediate removal of the waste is necessary to protect public health and safety or the environment, the Department may authorize the removal of the waste to a selected receiving facility by transporters who do not have identification numbers, licenses or manifests under this subchapter.
(d) A transporter shall:
(1) Clean up an infectious or chemotherapeutic waste discharge or spill that occurs during transportation or take action that may be required or approved by the Department so that the discharge or spill no longer presents a hazard to public health, public safety or the environment.
(2) File a complete report in writing concerning the incident with the Department's central office. The report shall include, at a minimum, a detailed description of the clean-up operation and the disposition of the waste, and the information required by subsection (a).
§ 284.633. Safety.
A transporter of infectious or chemotherapeutic waste shall provide adequate personnel training to ensure transport activities are conducted safely, in compliance with applicable laws and regulations, and according to the contingency plan approved under § 284.632 (relating to infectious or chemotherapeutic waste discharges or spills).
§ 284.634. Annual report.
(a) A transporter shall submit to the Department's Central Office an annual report. The report shall be submitted by the end of March of each calendar year. The report shall be submitted on forms supplied by the Department.
(b) The annual report shall be based on the shipments of infectious or chemotherapeutic waste during the previous calendar year, and shall include the following:
(1) The name, location, telephone number and permit identification number of each processing or disposal facility to which the transporter delivered infectious or chemotherapeutic waste.
(2) The weight or volume of each type of infectious or chemotherapeutic waste transported.
(3) When more than one transporter is used to transport a single shipment of infectious or chemotherapeutic waste from the generator to the processing or disposal facility, only the first transporter shall be required to submit information for that shipment on the annual report.
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