[43 Pa.B. 4858]
[Saturday, August 24, 2013]
[Continued from previous Web Page]
Subchapter C. TRANSFER FACILITIES § 284.201. Scope.
This subchapter sets forth application and operating requirements for a person or municipality that operates a transfer facility for [infectious] regulated medical or chemotherapeutic waste. The requirements in this subchapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management—general provisions).
§ 284.210. Application requirements.
An application to operate a transfer facility shall comply with §§ 279.101—279.111 [(relating to general requirements)].
§ 284.220. Operating requirements.
A person or municipality that operates a transfer facility shall comply with [§§ 279.201, 279.202, 279.211—279.223, 279.231—279.234, 279.241—279.243, 279.251, 279.252, 279.261 and 279.262] Chapter 279, Subchapters A and C (relating to general; and operating requirements for transfer facilities).
Subchapter D. PROCESSING FACILITIES § 284.301. Scope.
This subchapter sets forth application and operating requirements for a person or municipality that operates a processing facility, other than a transfer or composting facility, for [infectious] regulated medical or chemotherapeutic waste. The requirements in this subchapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management—general provisions).
§ 284.311. Plan for monitoring.
An application for a processing facility for [infectious] regulated medical waste shall contain a plan, including necessary designs, procedures and test protocols on forms provided by the Department, for meeting the requirements of § 284.321 (relating to [infectious] regulated medical waste monitoring requirements), including the following:
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§ 284.320. Operating requirements.
A person or municipality that operates a processing facility shall comply with [§§ 283.201, 283.202, 283.211—283.223, 283.231—283.234, 283.241, 283.242, 283.251—283.253, 283.261, 283.262, 283.271 and 283.272] Chapter 283, Subchapter C (relating to operating requirements).
§ 284.321. [Infectious] Regulated medical waste monitoring requirements.
(a) A person or municipality that disinfects [infectious] regulated medical waste shall monitor the waste to ensure the following:
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(2) For other disinfection processes, both of the following are met:
(i) The process shall be capable of inactivating [vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites and] mycobacteria at a 6 log 10 reduction or greater.
(ii) The process shall be capable of inactivating [B.] Geobacillus stearothermophilus spores, [B.] Bacillus pumilus or [B. subtilis] Bacillus atrophaeus spores at a 4 log 10 reduction or greater.
(b) The operator of a facility that incinerates or thermally processes [infectious] regulated medical waste shall submit to the Department a microbiological analysis of a composite sample of the processing or ash residue on forms provided by the Department at [a minimum, quarterly] least annually during the life of the facility.
(c) The operator of a facility that incinerates [infectious] regulated medical waste shall submit to the Department, at least annually during the life of the facility, a chemical analysis of composite samples of the ash residue on forms provided by the Department.
(d) If the facility disinfects [infectious] regulated medical waste by means other than incineration or thermal processing, the operator shall perform a microbiological analysis of indicators removed from the processed waste. The analysis shall be conducted at a minimum, every 40 hours during the operational life of the facility, unless otherwise provided in a permit. The analyses shall be made available to the Department upon request.
(e) Unless the Department approves another indicator or test in writing, the following indicators shall be used to establish and verify the following processes:
(1) For autoclaving, spores of [Bacillus] Geobacillus stearothermophilus.
(2) For dry heat, gas or chemical disinfection, spores of Bacillus [subtilis] atrophaeus variety niger (globigii). Ethylene oxide may not be used for gas disinfection.
* * * * *
(f) Indicators used for methods of disinfection other than incineration or thermal processing shall be located prior to disinfection at a point within the load where disinfection will be most difficult to achieve.
(g) [Infectious] Regulated medical waste will be considered to be infectious after disinfection, unless one of the following has occurred:
* * * * *
(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] regulated medical or chemotherapeutic waste incineration; and storage and containment of processing residue from [an infectious] a regulated medical or chemotherapeutic waste processing facility).
(j) Ash or other processing residue shall be transported in accordance with § 284.511 or § 284.514 (relating to transportation of ash residue from [infectious] regulated medical or chemotherapeutic waste incineration; and transportation of processing residue from [an infectious] a regulated medical or chemotherapeutic waste facility).
(k) Compactors, grinders or similar devices may not be used to reduce the volume of [infectious] regulated medical waste before the waste has been rendered noninfectious. If the volume reduction device is within a continuous, enclosed disinfection process and part of one processing system, then the reduction device may be used.
(l) The operator of [an infectious] a regulated medical waste processing facility shall dispose of ash or other processing residue from the facility in a landfill that has been approved by the Department to accept the waste, if the waste is disposed in this Commonwealth.
(m) [In addition to other applicable requirements, an autoclave facility shall comply with the following:] An autoclave facility shall comply with all applicable requirements and is prohibited from processing pathological waste or chemotherapeutic waste.
[(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.]
(n) Unless otherwise approved in writing by the Department, an operator of an autoclave facility shall employ the procedures in § 284.322 (relating to autoclave validation testing requirements) to validate the operating parameters and protocols of the processing equipment. These procedures shall be employed in the following circumstances:
(1) When a new autoclave is installed.
(2) When an autoclave is modified with respect to hardware, software, controls or ancillary equipment.
(3) To validate existing systems by ______ , (Editor's Note: The blank refers to 6 months after the effective date of adoption of this proposed rulemaking.) and at a frequency specified by the manufacturer, but not less than 1 year.
(4) When a significant change in the waste stream occurs or a problem is evident.
(o) The facility shall maintain a record of the autoclave validation testing protocols and procedures.
(Editor's Note: The following section is new and printed in regular type to enhance readability.)
§ 284.322. Autoclave validation testing requirements.
Autoclave operating parameters shall be established in accordance with the following:
(1) For facilities with one autoclave or multiple autoclaves that are not identical, each autoclave must have an initial validation test that establishes its operating parameters.
(2) For facilities with multiple autoclaves that are identical, one autoclave may have an initial validation test that establishes the operating parameters for all identical autoclaves at that facility.
(3) Autoclaves shall be tested using the manufacturer's recommended vacuum pulse plan, operating temperature, operating pressure and residence time at the maximum weight and with the most difficult heat transfer challenge anticipated with the indicators located where disinfection would be most difficult to achieve.
(4) If multiple vacuum pulse plans, residence times, temperatures and pressures are recommended, the autoclave shall be tested to validate its performance at each recommended vacuum pulse plan, residence time, temperature and pressure. If a test fails, more stringent operating parameters shall be used incrementally until a satisfactory test and set of operating parameters is determined.
(5) Autoclave operating parameters must be validated to achieve a minimum of 250°F or 121°C measured at a point where disinfection would be most difficult to achieve.
(6) The residence time required to achieve a 6 log 10 reduction of mycobacteria and a 4 log 10 reduction of Geobacillus stearothermophilus spores for the level of heat transfer challenge selected shall be the residence time set into that autoclave's controls.
(7) The vacuum pulse plan, residence time, operating temperature and operating pressure established in the validation test form the permitted operating parameters for the autoclave tested.
Subchapter E. SEGREGATION AND STORAGE § 284.401. Scope.
This subchapter sets forth operating requirements for a person or municipality that stores [infectious] regulated medical or chemotherapeutic waste, ash residue from [infectious] regulated medical or chemotherapeutic waste incineration and processing residue from [an infectious] a regulated medical 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—285.115 and 285.121 [(relating to general; and types of storage)].
§ 284.411. [Basic storage requirements] Segregation.
[(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 minicipal and infectious waste if it is sorted and separately containerized and if it is moved to an onsite incinerator.]
(a) Regulated medical waste and chemotherapeutic waste shall be segregated at the point of origin at the generating facility into the following three categories:
(1) Regulated medical waste, excluding pathological waste.
(2) Pathological waste.
(3) Chemotherapeutic waste.
(b) Each category of waste segregated under subsection (a) shall be placed in a separate container, except used sharps that qualify as regulated medical waste, which may be placed in a chemotherapeutic waste sharps container.
(c) When bags are used as containers to segregate the waste, the bags must be fluorescent orange, orange-red or red in color for regulated medical waste and yellow in color for chemotherapeutic waste.
(d) When bags are used to segregate and store the waste, the requirements of § 284.413 (relating to storage containers) must be satisfied.
§ 284.412. [Sorting] Basic storage requirements.
[(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 containerized infectious waste may be placed together into another container for onsite handling or offsite transportation.]
(a) After regulated medical and chemotherapeutic waste has been segregated and collected for transportation to an onsite or offsite processing facility, the 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 regulated medical waste 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 (<=°C or <=45°F) or freezing (<=—18°C or <=0°F) 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 regulated medical or chemotherapeutic waste shall be secured to deny access to unauthorized persons.
(ii) Enclosures and containers shall be marked with prominent warning signs indicating the storage of regulated medical or chemotherapeutic waste.
(b) Enclosures at a waste generating or processing facility that are used for the storage of regulated medical or chemotherapeutic waste must be constructed of finish materials that are impermeable and capable of being readily maintained in a sanitary condition. Exhaust air from storage areas must be ventilated to minimize human exposure.
(c) Regulated medical and chemotherapeutic waste may not be commingled with other waste.
(d) The generator may store regulated medical 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 regulated medical waste if it is sorted and separately containerized and if it is moved to an onsite incinerator.
§ 284.413. [Duration of storage of infectious waste for generators] Storage containers.
[(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).]
(a) Regulated medical 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 placed in containers that are:
(1) Rigid.
(2) Tightly lidded.
(3) Puncture resistant.
(c) In addition to the requirements of subsection (a), regulated medical waste fluids in quantities greater than 20 cubic centimeters and chemotherapeutic waste fluids shall be placed in containers that are:
(1) Break resistant.
(2) Tightly lidded or tightly stoppered.
(d) When bags are used as the only 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 must be constructed of material of sufficient single thickness strength to meet the following:
(i) The ASTM Standard D1709, 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, 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 must include one of the following certifications indicating that the ASTM standards have been met:
(i) Each bag must contain a printed certification by the manufacturer.
(ii) The manufacturer may issue a certification letter to the regulated medical or chemotherapeutic waste generator and print a certification on each packaged lot of the bags.
(4) Bags must 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 must be fluorescent orange, orange-red or red in color for regulated medical waste and yellow in color for chemotherapeutic waste and contain colorants that are organic pigments with no heavy metal content.
§ 284.414. [Duration of storage of infectious waste for processors] Marking of containers.
[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.]
(a) For onsite or offsite transportation of regulated medical or chemotherapeutic waste, the following information must be provided on the outermost container:
(1) The words ''chemotherapeutic waste'' if chemotherapeutic waste is containerized.
(2) Until ______ (Editor's Note: The blank refers to 1 year after the effective date of adoption of this proposed rulemaking.), the words ''infectious waste'' or ''regulated medical waste'' if regulated medical waste is containerized.
(3) After ______ (Editor's Note: The blank refers to 1 year after the effective date of adoption of this proposed rulemaking.), the words ''regulated medical waste'' if regulated medical waste is containerized.
(4) The universal biohazard symbol that conforms to the design in 29 CFR 1910.1030(g)(1)(i)(B) (relating to bloodborne pathogens) and the word ''BIOHAZARD.''
(5) The date the container was full or the date that the generator sealed the container, whichever occurs earlier. If the container is a roll-off and the date is not recorded on the roll-off, a record of the date must be maintained at the generating facility and available for inspection by the transporter or Department for 1 year.
(b) For offsite transportation of regulated medical or chemotherapeutic waste, the following information must be provided on the outermost container:
(1) The name, address and telephone number of the generator.
(2) The name of the transporter and, if applicable, Department-issued regulated medical and chemotherapeutic waste transporter license number.
(c) Nonwall-mounted used sharps containers storing regulated medical waste must have fluorescent orange, orange-red or red markings and chemotherapeutic waste must have yellow markings. The markings must sufficiently identify the waste as regulated medical or chemotherapeutic waste.
(d) The information required under this section must be clearly legible and produced with indelible ink in a color that contrasts with the color of the container, such as black. If a label is used to provide the information, the label must be securely attached to the container.
§ 284.415. [Storage containers] Duration of storage of regulated medical waste for generators.
[(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.]
(a) Generators that store regulated medical waste onsite shall record on the container the date that the container was full or the date that the generator sealed the container, whichever occurs earlier. If the container is a roll-off and the date is not recorded on the roll-off, a record of the date must be maintained at the generating facility for 1 year.
(b) Regulated medical waste may not be stored for longer than 30 days from the date that the storage container is full or sealed by the generator, whichever occurs earlier.
(c) If the regulated medical waste becomes putrescent during the storage period identified in subsection (b), the waste shall be moved offsite within 3 business days for processing or disposal.
§ 284.416. [Marking of containers] Duration of storage of regulated medical waste for processors.
[(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.]
If the waste processing facility is separate from the waste generating facility, regulated medical 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 <=25°C or <=77°F.
(2) Seven days in a refrigerator at <=7°C or <=45°F.
(3) Thirty days in a freezer at <=—18°C or <=0°F.
§ 284.417. Reuse of containers.
(a) Nonrigid containers shall be managed as either [infectious] regulated medical 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] regulated medical 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] regulated medical waste or chemotherapeutic waste may be reused if one of the following applies:
* * * * *
(2) The surface of the container has been protected from direct contact with [infectious] regulated medical and chemotherapeutic waste, as applicable.
[(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] regulated medical or chemotherapeutic waste incineration.
(a) Ash residue from [infectious] regulated medical or chemotherapeutic waste incineration shall be stored in accordance with the following:
* * * * *
(2) On a pad for collecting a spill or release of ash that is no more permeable than 1 x 10-7 cm./sec.
(3) [To] In a manner to prevent the release, dispersal or discharge of ash residue into the air, water or onto land.
* * * * *
§ 284.419. Storage and containment of processing residue from [an infectious] a regulated medical or chemotherapeutic waste processing facility.
(a) Processing residue from [infectious] regulated medical 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:
* * * * *
(b) Processing residue from [an infectious] a regulated medical 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 § 284.501. Scope.
This subchapter sets forth the requirements for a person or municipality that collects and transports [infectious] regulated medical or chemotherapeutic waste, ash residue from [infectious] regulated medical or chemotherapeutic waste incineration and processing residue from [an infectious] a regulated medical 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] regulated medical or chemotherapeutic waste incineration.
(a) Ash residue from [infectious] regulated medical 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] regulated medical 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.] A generator's ash residue from regulated medical or chemotherapeutic waste incineration shall be transported separately from the ash residue of other generators.
(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.] Municipal waste from a generator may be commingled and transported with the generator's ash residue from regulated medical and chemotherapeutic waste incineration if the municipal waste and ash residue is being transported separately from the waste of other generators.
§ 284.512. Transportation of [infectious] regulated medical and chemotherapeutic waste; general provisions.
(a) General. This section sets forth general requirements for a person or municipality that transports [infectious] regulated medical or chemotherapeutic waste. Section 284.513 (relating to transportation of [infectious] regulated medical and chemotherapeutic waste; additional provisions) sets forth additional provisions relating to the transportation of the waste.
(b) Manner of transportation. [Infectious] Regulated medical and chemotherapeutic waste shall be transported in a manner that:
* * * * *
(4) Maintains the waste in a nonputrescent state, using refrigeration (<=7°C or <=45°F) or freezing (<=—18°C or <=0°F) when necessary.
* * * * *
(c) Containers.
(1) [Infectious] Regulated medical and chemotherapeutic waste shall be transported in containers that are:
* * * * *
(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.]
(v) Labeled in accordance with the requirements in § 284.414 (relating to marking of containers).
(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] requirements of paragraph (1), [infectious] regulated medical waste fluids—quantities greater than 20 cubic centimeters—and chemotherapeutic waste fluids shall be transported in containers that are:
* * * * *
(4) Bags meeting the requirements of § [284.415] 284.413 (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)] Type of vehicles. Vehicles for transporting [infectious] regulated medical or chemotherapeutic waste shall be noncompaction type vehicles.
(e) Commingling of waste. Regulated medical or chemotherapeutic waste may not be commingled with municipal waste or transported in the same vehicle as residual waste.
(f) Cleaning of vehicles. Load compartments of vehicles holding [infectious] regulated medical 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] regulated medical 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) Refrigeration. [Infectious] Regulated medical waste may [not] be kept in an unrefrigerated transport vehicle for [more than 48] up to 72 hours provided the waste is not putrescent. If the vehicle is refrigerated (<=7°C or <=45°F) or maintained at freezing temperatures (<=—18°C or <=0°F), the in-transit storage period may not exceed 5 days.
(h) Chutes. Chutes may not be used by generators, processors or transporters to transfer [infectious] regulated medical or chemotherapeutic waste at onsite or offsite locations.
§ 284.513. Transportation of [infectious] regulated medical and chemotherapeutic waste; additional provisions.
(a) This section sets forth additional requirements for the transportation of [infectious] regulated medical and chemotherapeutic waste. This section does not apply to vehicles used by a generator of less than 220 pounds of [infectious] regulated medical and chemotherapeutic waste per month for transporting [waste that he generated] the generator's own waste.
(b) Vehicles for transporting [infectious] regulated medical 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] regulated medical and chemotherapeutic waste license number, if applicable.
(2) A placard or decal containing the phrase ''[infectious] regulated medical waste'' or ''chemotherapeutic waste,'' or both, as applicable, 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)] 29 CFR 1910.1030(g)(1)(i)(B) (relating to bloodborne pathogens). [The placard or decal shall be capable of being read at a distance of 25 feet.]
(c) A vehicle used for transporting [infectious] regulated medical or chemotherapeutic waste shall contain, in a readily accessible place, a portable decontamination and spill containment unit, including at a minimum the following:
* * * * *
(2) One gallon of [hospital grade] EPA-approved 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] 284.413 (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.
* * * * *
(d) The surface of vehicles that have not been in direct physical contact with [infectious] regulated medical 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] a regulated medical or chemotherapeutic waste facility.
(a) Processing residue from [an infectious] a regulated medical 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] regulated medical or chemotherapeutic waste for each generator separately from other generators.
(c) A transporter may transport processing residue from [infectious] regulated medical 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] REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE
GENERAL PROVISIONS § 284.601. Scope.
This subchapter sets forth the Department's requirements for licensing of persons and municipalities that transport [infectious] regulated medical or chemotherapeutic waste.
§ 284.602. License requirement.
(a) Except as provided in subsection (b), a person or municipality may not transport [infectious] regulated medical 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] regulated medical or chemotherapeutic waste by generators.
(2) [Onside] Onsite movement of [infectious] regulated medical or chemotherapeutic waste by [owners or] operators of permitted [infectious] regulated medical or chemotherapeutic waste management facilities.
(3) Transportation by a generator of less than 220 pounds per month of [infectious] regulated medical or chemotherapeutic waste when transporting only [the infectious] the generator's own regulated medical or chemotherapeutic waste [he generated] if the manifesting requirements under § 284.701(b)(3) (relating to scope) are met.
(4) The transportation of [infectious] regulated medical 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] regulated medical or chemotherapeutic waste without first receiving an identification number. The number shall be one of the following:
* * * * *
LICENSE APPLICATION REQUIREMENTS § 284.611. General application requirements.
(a) An application for a license to transport [infectious] regulated medical 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:
* * * * *
(3) The average yearly total tonnage of [infectious] regulated medical and chemotherapeutic waste picked up or delivered in this Commonwealth.
* * * * *
(5) Information concerning terminal locations that will store [infectious] regulated medical and chemotherapeutic waste in-transit.
* * * * *
(9) A contingency plan consistent with § 284.632 (relating to [infectious] regulated medical or chemotherapeutic waste discharges or spills).
* * * * *
§ 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] regulated medical 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] a regulated medical 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.
* * * * *
(e) An applicant for a transporter license to transport [infectious] regulated medical 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:
* * * * *
LICENSE APPLICATION REVIEW § 284.623. Conditions of licenses.
* * * * *
(c) A license to transport [infectious] regulated medical and chemotherapeutic waste is nontransferable and nonassignable. A license applies to the licensee and its [employes] employees. 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] regulated medical 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.
OPERATIONAL REQUIREMENTS § 284.631. Basic limitations.
(a) A person or municipality subject to this subchapter that transports [infectious] regulated medical or chemotherapeutic waste shall comply with the following:
* * * * *
§ 284.632. [Infectious] Regulated medical or chemotherapeutic waste discharges or spills.
* * * * *
(b) In the event of a discharge or spill of [infectious] regulated medical 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:
* * * * *
(2) The transporter's name, address, the Department-issued [infectious] regulated medical and chemotherapeutic waste transporter license number and identification number.
* * * * *
(c) If a discharge or spill of [infectious] regulated medical 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] a regulated medical 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.
* * * * *
§ 284.633. Safety.
A transporter of [infectious] regulated medical 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] regulated medical or chemotherapeutic waste discharges or spills).
§ 284.634. Annual report.
* * * * *
(b) The annual report shall be based on the shipments of [infectious] regulated medical 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] regulated medical or chemotherapeutic waste.
(2) The weight or volume of each type of [infectious] regulated medical or chemotherapeutic waste transported.
(3) When more than one transporter is used to transport a single shipment of [infectious] regulated medical 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.
BOND § 284.641. Bond requirement.
(a) General. The applicant shall provide the Department a bond, secured by collateral as specified by this section and which bond is conditional upon compliance by the licensee with the requirements of the act, the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. §§ 6019.1—6019.6), referred to as the Infectious and Chemotherapeutic Waste Law, regulations thereunder, the terms and conditions of the license and Department orders issued to the licensee. The bond shall be consistent with, and subject to, the requirements of this section. The amount, duration, form, conditions and terms of the bond shall be specified by the Department. An additional bond amount will not be required of applicants that are also licensed hazardous waste transporters during the term of license or renewal thereof under this subchapter if the applicant or licensee submits a bond endorsement, including an increase in the amount of the bond of a minimum of $10,000, to the Department that includes liability for [infectious] regulated medical and chemotherapeutic waste transportation on the hazardous waste transporter bond.
(b) Approval by Department. A license to transport [infectious] regulated medical or chemotherapeutic waste will not be issued by the Department before the applicant for the license has filed a collateral bond payable to the Department on a form provided by the Department, and the bond has been approved by the Department.
* * * * *
(f) Review of bonds. Bonds will be reviewed for legality and form according to established Department procedures.
§ 284.642. Release of bond.
* * * * *
(b) The Department will not release a bond if the transporter is in violation of the act, 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 thereunder, the terms and conditions of the license or Department orders issued to the licensee, whether or not the violation results from [infectious] regulated medical or chemotherapeutic waste transportation.
* * * * *
§ 284.643. Bond forfeiture.
(a) The Department will declare a bond forfeit if the transporter is in violation of the act, 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 thereunder, the terms and conditions of the bond, the terms and conditions of the license or Department orders issued to the licensee, whether or not the violation results from [infectious] regulated medical or chemotherapeutic waste transportation.
* * * * *
Subchapter H. MANIFESTING FOR [INFECTIOUS] REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE
GENERAL § 284.701. Scope.
(a) Except as provided in [subsections (b) and (c)] subsection (b), this subchapter applies to a person or municipality that generates, transports, disposes or processes [infectious] regulated medical or chemotherapeutic waste or processed [infectious] regulated medical or chemotherapeutic waste that is recognizable.
(b) This subchapter does not apply to a person or municipality for the following activities:
(1) Onsite movement of [infectious] regulated medical or chemotherapeutic waste by generators.
(2) Onsite movement of [infectious] regulated medical or chemotherapeutic waste by [owners or] operators of permitted [infectious] regulated medical or chemotherapeutic waste management facilities.
(3) Transportation by a generator who generates less than 220 pounds per month of [infectious] regulated medical and chemotherapeutic waste if the following are met:
* * * * *
(iii) The generator carries and delivers a copy of this [record] log or shipping paper with the waste shipment to the offsite processing or disposal facility.
(4) The transportation of [used sharps from generators who generate less than 220 pounds per month of infectious and chemotherapeutic waste] regulated medical and chemotherapeutic waste if the following are met:
* * * * *
(ii) [The packaging meets the requirements of the United States Postal Service or other mail carriers.] The mailing standards of the United States Postal Service in 39 CFR 211.2 (relating to regulations of the Postal Service) and incorporated by reference into this chapter authorize the package to be mailed.
(iii) The package is mailed in compliance with United States Postal Service regulations.
(iv) The generator maintains a log or shipping paper containing the following information:
* * * * *
(5) The transportation by a generator [of] who generates and processes onsite less than 220 pounds per month of [infectious] regulated medical or chemotherapeutic waste [that he generates and processes onsite, but], which is recognizable waste, if the following are met:
(i) The generator only transports its own waste.
(ii) The generator records on a log or shipping paper the following information for each shipment:
* * * * *
[(ii)] (iii) A copy of the log or [record shall be carried and delivered] shipping paper shall be provided to the disposal facility by the transporter for each shipment of waste.
(6) The transportation through this Commonwealth of [infectious] regulated medical or chemotherapeutic waste generated outside this Commonwealth [and which] that is destined for processing or disposal outside this Commonwealth.
(7) The transportation of processed [infectious] regulated medical or chemotherapeutic waste to a disposal facility if the waste has been rendered unrecognizable.
[(c) This subchapter does not apply to a person or municipality which receives infectious or chemotherapeutic waste generated in this Commonwealth and which processes or disposes of the waste outside this Commonwealth in a state that provides a manifest or tracking form if the following are met:
(1) The state requires a manifest or tracking form for infectious or chemotherapeutic waste, regardless of whether the state requires a manifest or tracking form for infectious or chemotherapeutic waste as defined in this article.
(2) The generator obtains a manifest or tracking form for infectious or chemotherapeutic waste from that state.
(3) The generator, transporter and owner or operator of a processing or disposal facility comply with the requirements on the manifest or tracking form and applicable state or Federal law, managing the infectious or chemotherapeutic waste as if it were regulated waste under applicable law. For purposes of this subsection, applicable law includes the provisions of this subchapter that are expressly applicable to waste that will be transported outside this Commonwealth for processing or disposal.]
§ 284.702. Transfer facilities.
[(a) Infectious or] Regulated medical waste, chemotherapeutic waste or processed [infectious] regulated medical or chemotherapeutic waste that is recognizable may be transported to or from a transfer [facilty under this subchapter. The use of a transfer facility shall require two manifests, one for the transportation of waste to the facility, and one for the transportation of waste from the facility.] facility in accordance with the following:
[(b) If infectious or chemotherapeutic waste or processed waste which is recognizable is]
(1) The transfer facility is permitted by the Department.
(2) If transported to a transfer facility, the transfer facility shall be considered the designated facility for purposes of this subchapter.
[When the waste is] (3) If transported from the transfer facility to a processing or disposal facility, the transfer facility shall be considered the generator and the processing or disposal facility shall be considered the [new] designated facility for purposes of this subchapter.
§ 284.703. Recordkeeping.
[(a)] The records required under this subchapter shall be retained for at least [5] 2 years from the date on which the [report was required to be] record was prepared. Records shall be submitted to the Department upon request. The retention period shall be extended automatically during the course of an enforcement action or as requested by the Department.
[(b) Manifest copies shall be retained for at least 5 years from the date of shipment of the waste. Manifest copies retained under this subchapter shall be furnished to the Department upon request. The retention period shall be extended automatically during the course of an enforcement action or as requested by the Department.]
GENERATOR RESPONSIBILITIES § 284.711. Use of manifest.
[(a)] A generator who transports, or offers for transportation, [infectious] regulated medical or chemotherapeutic waste for offsite processing or disposal shall ensure proper segregation of [infectious] regulated medical and chemotherapeutic waste from other types of waste and prepare a [manifest according to the instructions supplied with the manifest] log or shipping paper as required under this subchapter. A processor who transports, or offers for transportation, processed [infectious] regulated medical or chemotherapeutic waste that is recognizable for offsite disposal shall be considered a generator for purposes of [manifesting. The manifest shall be in at least four parts] this subchapter.
[(b) If the waste is to be processed or disposed in this Commonwealth, the generator shall use one of the manifest formats prescribed by the Department.
(c) The manifest copies shall be distributed as follows:
(1) A four-part manifest shall be used by a generator who designates only one transporter.
(i) Copy 4 of the manifest is retained by the generator.
(ii) Copy 3 of the manifest is retained by the transporter.
(iii) Copy 2 of the manifest is retained by the owner or operator of the processing or disposal facility.
(iv) Copy 1 of the manifest is mailed to the generator by the owner or operator of the processing or disposal facility.
(2) A five-part manifest shall be used by a generator who designates two transporters.
(i) Copy 4 of the manifest is retained by the generator.
(ii) Copy 3A of the manifest is retained by the first transporter.
(iii) Copy 3 of the manifest is retained by the second transporter.
(iv) Copy 2 of the manifest is retained by the owner or operator of the processing or disposal facility.
(v) Copy 1 of the manifest is mailed to the generator by the owner or operator of the processing or disposal facility.
(3) A six-part manifest shall be used by a generator who designates three transporters.
(i) Copy 4 of the manifest is retained by the generator.
(ii) Copy 3B of the manifest is retained by the first transporter.
(iii) Copy 3A of the manifest is retained by the second transporter.
(iv) Copy 3 of the manifest is retained by the third transporter.
(v) Copy 2 of the manifest is retained by the owner or operator of the processing or disposal facility.
(vi) Copy 1 of the manifest is mailed to the generator by the owner or operator of the processing or disposal facility.
(d) If the waste is to be processed or disposed outside this Commonwealth, the generator shall obtain the manifest from the destination state. If the destination state does not supply the manifest, the generator shall use the manifest format required by the Department.]
§ 284.712. Preparation of manifest.
(a) The generator shall [provide the following information on each manifest] create a log or shipping paper of the following information and provide it to the transporter before the offsite transportation of the [manifested] waste occurs:
* * * * *
(2) [The total number of pages used to complete the manifest, counting the first page plus the number of continuation sheets, if any.
(3)] Each transporter's company name, identification number, Pennsylvania [infectious] regulated medical and chemotherapeutic waste transporter license number and telephone number. [If three transporters are designated by the generator, enter the third transporter's name, identification number, Pennsylvania infectious and chemotherapeutic waste transporter license number, telephone number and the words ''Transporter 3 sign here,'' in the Special Handling Instruction Section.
(4)] (3) The number of containers, types of containers and the total quantity of the waste by weight or volume.
[(5) The infectious or chemotherapeutic waste code number for each waste as indicated on the manifest instructions.
(6)] (4) The United States Department of Transportation proper shipping name, hazard class and identification number (UN or NA) for each waste identified by 49 CFR Subchapter C (relating to hazardous materials regulations), if applicable.
[(7)] (5) Special instructions and information necessary for proper handling of the waste during transportation, processing, storage or disposal, if any.
[(8)] (6) The printed or typed name and handwritten signature of the generator's authorized representative, and the date of shipment.
[(9)] (7) The printed or typed name and handwritten signature of the initial transporter's authorized representative, and the date of receipt.
[(10) The designated facility's name, site address, Pennsylvania State permit or identification number and phone number. One alternate facility's name, site address, Pennsylvania State permit or identification number and phone number may be designated on the manifest to receive the waste. A facility may only be designated if it has been approved by the Department to accept the generator's waste.]
(b) An authorized representative of the generator shall ensure that [the manifest has been completed and shall read the certification statement on the manifest prior to signing the manifest] a legible log or shipping paper has been completed.
(c) [The generator shall ensure before the waste is transported offsite that the required information on all parts of the manifest are capable of being read.] After the offsite transportation of the waste, the generator shall receive from the transporter and maintain as a record the log or shipping paper prepared by the transporter in accordance with § 284.722(f) (relating to preparation and use of manifest).
[(d) When the generator uses lab packs containing more than four different waste streams, the generator shall complete a continuation sheet (EPA Form 8700-22A).
(e) For a shipment containing more than four different waste streams, which is not a lab pack, the generator shall complete additional manifests as necessary for waste streams in excess of four, according to the instructions on the manifest.]
§ 284.713. [Generator's distribution of copies] (Reserved).
[(a) Except as provided in subsection (b), the generator shall detach and retain copy 4 of the manifest.
(b) A generator located in this Commonwealth and designating a facility in a state that supplies the manifest shall provide information and distribute copies as required by the manifest in accordance with instructions supplied with the manifest and retain one copy of the manifest.
(c) The generator shall give the transporter the remaining copies of the manifest before the transporter leaves the generator's property.]
§ 284.714. Exception reporting.
(a) A generator that does not receive a [copy of the manifest with the handwritten signature of the owner or operator of the designated processing or disposal facility within 20] log or shipping paper indicating the designated facility that received its waste within 30 days of the date the generator's waste was accepted by the initial transporter shall:
(1) Contact the transporter or the [owner or] operator of the designated facility, or both, to determine the status of the [infectious or chemotherapeutic waste or processed recognizable waste] shipment.
* * * * *
(b) [A generator shall notify by telephone the Department's appropriate regional office and submit an exception report to the Department's central office if] If the generator has not received a [copy of the manifest with the handwritten signature of the owner or operator of the designated processing or disposal facility] log or shipping paper indicating the designated facility that received its waste from the transporter within 35 days of the date the generator's waste was accepted by the initial transporter, the generator shall notify the Department's appropriate regional office by telephone and submit an exception report to the Department's central office.
(c) The exception report shall include the following:
(1) [A legible copy of the manifest] A record of the waste for which the generator does not have confirmation of delivery.
* * * * *
TRANSPORTER RESPONSIBILITIES § 284.721. [Basic requirements] (Reserved).
[Except as provided in § 284.701 (relating to scope), a transporter may not accept infectious or chemotherapeutic waste or processed infectious or chemo therapeutic waste that is recognizable unless it is accompanied by a manifest which has been completed and signed by the generator or the generator's authorized agent under § 284.712 (relating to preparation of manifest).]
§ 284.722. Preparation and use of manifest.
(a) Before transporting [infectious] regulated medical or chemotherapeutic waste or processed [infectious] regulated medical or chemotherapeutic waste that is recognizable, the transporter shall [print or type his name, sign and date the manifest, and, by the signature, acknowledge acceptance of the waste from the generator] provide the generator with a dated, handwritten signature of an authorized representative of the transporter acknowledging that the transporter has accepted the waste from the generator on the date of acceptance.
(b) [Before leaving the generator's property, the transporter shall ensure that all copies of the manifest are properly completed and capable of being read, and shall return copy 4 of the manifest to the generator according to the instructions on the manifest.
(c)] The transporter shall ensure that the [manifest] log or shipping paper required under subsections (c) and (d) accompanies the waste shipment.
[(d) The transporter may not add additional information to the generator's or designated facility's portions of the manifest or alter the generator's information on a manifest as it existed when the generator signed the manifest.
(e)] (c) A transporter who delivers [infectious] regulated medical or chemotherapeutic waste or processed recognizable waste to the designated processing or disposal facility shall create a log or shipping paper containing the following information:
(1) [Obtain on the manifest the date of delivery, the printed or typed name and handwritten signature of the owner or operator of the designated facility.] The date that each container of waste was delivered to a designated facility.
(2) [Retain copy 3 of the manifest according to the instructions supplied with the manifest.] The name and address of the designated facility for each container of waste.
[(3) Give the remaining copies of the manifest to the owner or operator of the designated facility.
(f)] (d) The transporter who delivers [infectious] regulated medical or chemotherapeutic waste to another transporter shall create a log or shipping paper containing the following information:
(1) [Obtain the following information on the original manifest and on an additional copy of the manifest provided by the generator:
(i)] The date [of delivery] that each container of waste was delivered to the subsequent transporter.
[(ii)] (2) The [printed or typed] name and address of the subsequent transporter [and his handwritten signature] that received each container of waste.
[(2) Retain the additional copy signed by the subsequent transporter.
(3) Give the remaining additional copies of the manifest to the subsequent transporter.]
(e) At the time the waste is delivered to the designated facility, the transporter shall provide the operator of the designated facility with a log or shipping paper containing the following information:
(1) The name, mailing address and telephone number of the generator for each container of waste.
(2) The number of containers, types of containers and the total quantity of the waste by weight or volume for each generator.
(f) After the waste has been transported to the designated facility, the transporter shall provide the generator with a log or shipping paper containing the following information:
(1) The name, mailing address and telephone number of each designated facility that received each container of the generator's waste.
(2) The number of containers, types of containers and the total quantity of the waste by weight or volume received by each designated facility.
(3) The date that each designated facility received each container of the generator's waste.
(4) Acknowledgment from the designated facility that it accepted each container of the generator's waste.
§ 284.723. [Waste delivery] (Reserved).
[(a) The transporter shall deliver the entire quantity of infectious or chemotherapeutic waste or processed infectious or chemotherapeutic waste that is recognizable which he has accepted from a generator, a processor or a transporter to one of the following:
(1) The designated facility listed on the manifest by the generator.
(2) The next designated transporter listed on the manifest by the generator.
(b) If the waste cannot be delivered in accordance with subsection (a), the transporter shall do one of the following:
(1) Return the waste to the generator.
(2) Deliver the waste to the alternate facility designated by the generator on the original manifest.
(3) Receive from the generator another properly completed manifest designating an alternate facility from the originally designated facility before transporting the waste to the alternate facility.]
§ 284.724. Transportation limitations.
(a) A transporter may not accept or transport a shipment of [infectious] regulated medical or chemotherapeutic waste or processed [infectious] regulated medical or chemotherapeutic waste that is recognizable if:
(1) The waste is in containers or packaging which appear to be leaking, damaged or otherwise in violation of § [284.415] 284.413 or § 284.512 (relating to storage containers; and transportation of [infectious] regulated medical and chemotherapeutic waste; general provisions).
(2) The waste is not labeled or identified as required by § [284.416] 284.414 (relating to marking of containers).
(3) The number and type of containers and quantity of waste to be transported do not appear to correspond with the number and type of containers and quantity of waste stated [on the manifest] in the generator's log or shipping paper at the time of acceptance by the transporter.
[(4) Any copy of the manifest is not completed according to the manifest instructions or if information on copies of the manifest is not capable of being read.]
(b) A transporter shall ensure that the waste shipment complies with applicable United States Department of Transportation regulations and 67 Pa. Code Part I (relating to Department of Transportation).
FACILITY RESPONSIBILITIES § 284.731. Scope.
Sections 284.732[—] and 284.734 (relating to use of manifest; [distribution of copies;] and significant discrepancies) apply to [owners and] operators of waste processing or disposal facilities that receive [infectious] regulated medical or chemotherapeutic waste or processed [infectious] regulated medical or chemotherapeutic waste that is recognizable from offsite sources.
§ 284.732. Use of manifest.
(a) Except for waste managed in accordance with § 284.701 (relating to scope), an [owner or] operator of a designated facility may not accept shipments of [infectious] regulated medical or chemotherapeutic waste or processed [infectious] regulated medical or chemotherapeutic waste that is recognizable from offsite sources unless the shipment is accompanied by [a Pennsylvania manifest in accordance with] a log or shipping paper as required under this subchapter.
(b) The [owner or] operator of the designated facility shall:
(1) [Print or type his name, and sign and date each copy of the manifest to certify that the waste covered by the manifest was received.] Examine the records of the transporter.
(2) Note significant discrepancies in the [information on the manifest] log or shipping paper of the generator and transporter, as defined in § 284.734 (relating to significant discrepancies).
(3) [Note the rejection in the discrepancy indication space, and sign and date the manifest in accordance with paragraph (1) if either partially or totally rejecting the waste.] Provide the transporter with a dated, handwritten signature from an authorized representative of the facility acknowledging that it has accepted the waste from the transporter on that date.
[(c) The owner or operator of the designated facility may not alter or add to the information in the generator or transporter sections of the manifest form.
(d) The owner or operator of the designated facility shall ensure that information entered on the manifest is capable of being read on all copies of the manifest.]
§ 284.733. [Distribution of copies] (Reserved).
[The owner or operator of a designated facility or an authorized representative shall:
(1) Immediately upon signing the manifest to either partially or totally accept or reject the waste shipment, give the transporter copy 3 of the signed manifest.
(2) Retain copy 2 of the manifest for his records.
(3) Send copy 1 of the manifest to the generator within 14 days of the date of receipt of the waste.]
§ 284.734. Significant discrepancies.
(a) This section applies if there is a significant discrepancy in [a manifest] the logs or shipping papers of the generator and transporter. A discrepancy is a difference between the quantity or type of waste designated [on the manifest] in the log or shipping paper, and the quantity or type of waste a facility actually receives. A significant discrepancy occurs if one or more of the following apply:
* * * * *
(2) There is a variation in piece count, for batch waste, excluding 1% variation for generator-loaded trailers.
* * * * *
(b) If there is a significant discrepancy in [a manifest] the logs or shipping papers, the [owner or] operator shall attempt to reconcile the discrepancy before the waste is processed or disposed of at the facility or before the waste is accepted at a transfer facility. If the discrepancy is not resolved within 3 business days of receipt of the waste, the [owner or] operator shall immediately notify the appropriate regional office of the Department by telephone. Within 7 business days of receipt of the waste, the [owner or] operator shall also send a letter to the regional office describing the discrepancy and attempts to reconcile it [, and include a legible copy of the relevant manifest].
CHAPTER 285. STORAGE, COLLECTION AND TRANSPORTATION OF MUNICIPAL WASTE
Subchapter A. STORAGE OF MUNICIPAL WASTE
ADDITIONAL REQUIREMENTS FOR CERTAIN TYPES OF WASTE § 285.131. Storage and containment of ash residue from municipal waste incineration, including from [infectious] regulated medical or chemotherapeutic waste incineration.
(a) Ash residue from municipal waste incineration, including from [infectious] regulated medical or chemotherapeutic waste incineration, shall be stored in accordance with the following:
* * * * *
(b) Ash residue from [an infectious] a regulated medical or chemotherapeutic waste incinerator 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).
ADDITIONAL REQUIREMENTS FOR [INFECTIOUS] REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE §§ 285.141—285.145. (Reserved).
Subchapter B. COLLECTION AND TRANSPORTATION OF MUNICIPAL WASTE
GENERAL PROVISIONS § 285.218. Signs on vehicles.
A vehicle or conveyance that is ordinarily or primarily used for the transportation of solid waste shall bear a sign that meets the following:
* * * * *
(2) The sign shall include the specific type of solid waste transported by the vehicle or conveyance.
(i) [Infectious] Regulated medical or chemotherapeutic waste shall be designated: [Infectious] Regulated Medical/Chemotherapeutic Waste.
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TYPES OF WASTE § 285.221. Transportation of ash residue from municipal waste incineration and from [infectious] regulated medical or chemotherapeutic waste incineration.
(a) Ash residue from municipal waste incineration and from [infectious] regulated medical 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] regulated medical 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] regulated medical or chemotherapeutic waste.
(d) A transporter may transport ash residue from [an infectious] a regulated medical 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.
ARTICLE IX. RESIDUAL WASTE MANAGEMENT
CHAPTER 287. RESIDUAL WASTE MANAGEMENT—GENERAL PROVISIONS
Subchapter A. GENERAL § 287.1. Definitions.
The following words and terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:
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Special handling waste—Solid waste that requires the application of special storage, collection, transportation, processing or disposal techniques due to the quantity of material generated or its unique physical, chemical or biological characteristics. The term includes dredged material, sewage sludge, [infectious] regulated medical waste, chemotherapeutic waste, ash residue from a solid waste incineration facility, friable asbestos-containing waste, PCB-containing waste, waste oil that is not hazardous waste, fuel contaminated soil, waste tires and water supply treatment plant sludges.
* * * * *
§ 287.2. Scope.
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(b) Management of the following types of residual waste is subject to Article VIII (relating to municipal waste) instead of this article, and shall be regulated as if the waste is municipal waste regardless of whether the waste is a municipal waste or residual waste:
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(2) [Infectious] Regulated medical and chemotherapeutic waste. The terms shall have the same meaning for residual waste as set forth in § 271.1.
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CHAPTER 288. RESIDUAL WASTE LANDFILLS
Subchapter D. ADDITIONAL REQUIREMENTS FOR CLASS I RESIDUAL WASTE LANDFILLS
ADDITIONAL OPERATING REQUIREMENTS—GENERAL § 288.423. Minimum requirements for acceptable waste.
* * * * *
(b) A person or municipality may not dispose of municipal waste or special handling waste at a Class I residual waste landfill, except that the Department may, in the permit, approve the storage or disposal of the following types of waste generated by the operator:
* * * * *
(2) Special handling waste, other than sewage sludge, [infectious] regulated medical or chemotherapeutic waste, waste oil or ash residue from the incineration of municipal waste.
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CHAPTER 299. STORAGE AND TRANSPORTATION OF RESIDUAL WASTE
Subchapter B. STANDARDS FOR COLLECTING AND TRANSPORTING OF RESIDUAL WASTE
GENERAL PROVISIONS § 299.220. Signs on vehicles.
A vehicle or conveyance that is ordinarily or primarily used for the transportation of solid waste shall bear a sign that meets the following:
* * * * *
(2) The sign shall include the specific type of solid waste transported by the vehicle or conveyance.
(i) [Infectious or chemotherapeutic waste shall be designated: Infectious/Chemotherapeutic waste.
(ii)] Other municipal waste shall be designated: Municipal Waste.
[(iii)] (ii) Residual waste shall be designated: Residual Waste.
[(iv)] (iii) Mixed municipal and residual waste shall be designated: Municipal/ Residual Waste.
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[Pa.B. Doc. No. 13-1585. Filed for public inspection August 23, 2013, 9:00 a.m.]
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