PENNSYLVANIA - ENVIRONMENTAL ISSUES

January 1, 2008

Pennsylvania state laws and regulations that affect your medical practice

1. How does Pennsylvania regulate medical waste?

Permit-by-rule for infectious or chemotherapeutic waste processing facilities; qualifying facilities; general requirements:

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

(i) Processing of pathological waste is prohibited.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(ii) The dates and results of calibration.

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

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

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

(9) For incineration facilities, an air quality permit shall be obtained under the Air Pollution Control Act.

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

(i) The name and address of the facility.

(ii) A description of the processing activity.

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

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

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

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

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

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

25 PA ADC § 284.2

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) The process shall be capable of inactivating B. 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 stearothermophilus.

(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.

25 PA ADC § 284.321

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.

25 PA ADC § 284.411

Sorting:

(a) Infectious and chemotherapeutic waste shall be placed in separate containers from other waste at the point of origin 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 container:

(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.

25 PA ADC § 284.412

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).

25 PA ADC s 284.413

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.

25 Pa. Code § 284.414

Storage containers:

(a) Infectious and chemotherapeutic waste shall be placed in containers that are:

(1) Leakproof;

(2) Impervious to moisture; and

(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; and

(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; and

(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.

25 PA ADC s 284..415

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 (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.

25 PA ADC § 284.416

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.

25 PA ADC § 284.417

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 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).

25 PA ADC s 284.418

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).

25 PA ADC § 284.419

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.

25 PA ADC § 284.511

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; and

(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; and

(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.

25 PA ADC § 284.512

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.

25 PA ADC § 284.514

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 (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.

25 PA ADC § 284.513

Scope:

(a) Except as provided in subsections (b) and (c), this subchapter applies to a person or municipality that generates, transports, disposes or processes infectious or chemotherapeutic waste or processed infectious 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 or chemotherapeutic waste by generators.

(2) Onsite movement of infectious or chemotherapeutic waste by owners or operators of permitted infectious or chemotherapeutic waste management facilities.

(3) Transportation by a generator who generates less than 220 pounds per month of infectious and chemotherapeutic waste if the following are met:

(i) The generator only transports his own waste.

(ii) The generator records on a log or shipping paper the following information for each shipment:

(A) The name, address and telephone number of the generator of the waste.

(B) The quantity of the waste transported and accepted by the processing or disposal facility.

( C ) The date the waste is transported and accepted by the processing or disposal facility.

(iii) The generator carries and delivers a copy of this record 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 if the following are met:

(i) The package is sent to a permitted processing or disposal facility in this Commonwealth or to an out-of-State facility by certified mail, return receipt requested, indicating the name and address of the sender, the name of the addressee, the signature of the addressee, the date of delivery and the address where delivered or by utilizing an alternate tracking system approved in writing by the Department if applicable.

(ii) The packaging meets the requirements of the United States Postal Service or other mail carriers.

(iii) The generator maintains a log containing the following information:

(A) The weight of the waste transported.

(B) The date of shipment.

( C ) The name and address of each processing or disposal facility to which the generator is shipping the waste by the United States Postal Service or other mail carrier.

(5) The transportation by a generator of less than 220 pounds per month of infectious or chemotherapeutic waste that he generates and processes onsite, but which is recognizable waste, if the following are met:

(i) The generator records on a log or shipping paper the following information for each shipment:

(A) The name, address and telephone number of the generator of the waste.

(B) The quantity of the waste transported and accepted by the disposal facility.

( C ) The name, address and telephone number of the transporter for each shipment of waste. If applicable, the log or shipping paper shall include the identification number of a licensed transporter.

(D) The date the waste is transported and accepted by the processing or disposal facility.

(ii) A copy of the log or record shall be carried and delivered to the disposal facility by the transporter for each shipment of waste.

(6) The transportation through this Commonwealth of infectious or chemotherapeutic waste generated outside this Commonwealth and which is destined for processing or disposal outside this Commonwealth.

(7) The transportation of processed infectious 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.

25 PA ADC § 284.701

Transfer facilities:

(a) Infectious or chemotherapeutic waste or processed infectious or chemotherapeutic waste that is recognizable may be transported to or from a transfer facility 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.

(b) If infectious or chemotherapeutic waste or processed waste which is recognizable is transported to a transfer facility, the transfer facility shall be considered the designated facility for purposes of this subchapter. When the waste is 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.

25 PA ADC § 284.702

Recordkeeping:

(a) The records required under this subchapter shall be retained for at least 5 years from the date on which the report was required to be prepared. 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.

25 PA ADC § 284.703

Use of manifest

(a) A generator who transports, or offers for transportation, infectious or chemotherapeutic waste for offsite processing or disposal shall ensure proper segregation of infectious and chemotherapeutic waste from other types of waste and prepare a manifest according to the instructions supplied with the manifest. A processor who transports, or offers for transportation, processed infectious 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.

(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.

25 PA ADC § 284.711

Preparation of manifest:

(a) The generator shall provide the following information on each manifest before the offsite transportation of the manifested waste occurs:

(1) The name, mailing address and telephone number of the generator.

(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 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) 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) 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) Special instructions and information necessary for proper handling of the waste during transportation, processing, storage or disposal, if any.

(8) The printed or typed name and handwritten signature of the generator's authorized representative, and the date of shipment.

(9) 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.

( 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.

(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.

25 PA ADC § 284.712

Generator's distribution of copies:

(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.

25 PA ADC § 284.713

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 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.

(2) Notify the Department's appropriate regional office by telephone within 1 business day of the status of the 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 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 within 35 days of the date the generator's waste was accepted by the initial transporter.

( c ) The exception report shall include the following:

(1) A legible copy of the manifest for which the generator does not have confirmation of delivery.

(2) A cover letter signed by the generator or an authorized representative explaining the efforts taken to locate the waste shipment and the results of those efforts.

25 PA ADC § 284.714

Basic requirements:

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).

25 PA ADC § 284.721

Preparation and use of manifest:

(a) Before transporting infectious or chemotherapeutic waste or processed infectious 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.

(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 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) A transporter who delivers infectious or chemotherapeutic waste or processed recognizable waste to the designated processing or disposal facility shall:

(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.

(2) Retain copy 3 of the manifest according to the instructions supplied with the manifest.

(3) Give the remaining copies of the manifest to the owner or operator of the designated facility.

(f) The transporter who delivers infectious or chemotherapeutic waste to another transporter shall:

(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 to the subsequent transporter.

(ii) The printed or typed name of the subsequent transporter and his handwritten signature.

(2) Retain the additional copy signed by the subsequent transporter.

(3) Give the remaining additional copies of the manifest to the subsequent transporter.

25 PA ADC § 284.722

Waste delivery:

(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.

25 PA ADC § 284.723

Transportation limitations

(a) A transporter may not accept or transport a shipment of infectious or chemotherapeutic waste or processed infectious 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 or § 284.512 (relating to storage containers; and transportation of infectious and chemotherapeutic waste; general provisions).

(2) The waste is not labeled or identified as required by § 284.416 (relating to marking of containers).

(3) The number and type of containers and quantity of waste to be transported do not correspond with the number and type of containers and quantity of waste stated on the manifest.

(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).

25 PA ADC § 284.724

Scope:

Sections 284.732-284.734 (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 or chemotherapeutic waste or processed infectious or chemotherapeutic waste that is recognizable from offsite sources.

25 PA ADC § 284.731

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 or chemotherapeutic waste or processed infectious or chemotherapeutic waste that is recognizable from offsite sources unless the shipment is accompanied by a Pennsylvania manifest in accordance with 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.

(2) Note significant discrepancies in the information on the manifest, 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.

( 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.

25 PA ADC § 284.732

Distribution of copies

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.

25 PA ADC § 284.733

Significant discrepancies:

(a) This section applies if there is a significant discrepancy in a manifest. A discrepancy is a difference between the quantity or type of waste designated on the manifest, and the quantity or type of waste a facility actually receives. A significant discrepancy occurs if one or more of the following apply:

(1) There is a variation greater than 5% in weight, for bulk waste.

(2) There is a variation in piece count, for batch waste.

(3) There is a difference in waste type which can be discovered by inspection or waste analysis.

(b) If there is a significant discrepancy in a manifest, the owner or operator shall attempt to reconcile the discrepancy before the waste is processed or disposed at the facility or before the waste is accepted at a transfer facility. If the discrepancy is not resolved within 3 days of receipt of the waste, the owner or operator shall immediately notify the appropriate regional office of the Department by telephone. Within 7 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.

25 PA ADC § 284.734

2. How are physicians regulated by the Occupational Safety and Health Act (OSHA)?

Physicians in the clinical practice of medicine are subject to the OSHA regulations which protect employees who come into contact with blood and other potentially infectious agents.

3. What are the major requirements of the regulations?

The major requirements are:

A. Universal precautions, free vaccinations and post-exposure treatment.

The regulations require that all health care employers, including physicians, ensure that their employees follow universal precautions and have access to free hepatitis B vaccinations. "Universal precautions" is an approach to infection control where all human blood and certain bodily fluids are treated as if known to be infectious for HIV, and other bloodborne pathogens.

Post-exposure evaluation and treatment must also be provided, free-of-charge. This includes counseling, prophylaxis and AZT should it be recommended by a licensed health professional treating the employee.

B. Written Exposure Control Plan

The regulations require employers to develop a written exposure control plan which must identify the job classifications, procedures and tasks of employees who are exposed to blood and must specify the means used to protect such employees from infection. The plan must also set a schedule for implementing the methods for compliance and a procedure for the evaluation of circumstances surrounding exposure incidents.

Additionally, all exposure control plans must provide for the use of the following: 1) engineering controls, such as puncture-resistant containers for used needles; 2) work practice controls, such as rules that ensure employees are performing procedures in the safest way; 3) housekeeping controls, such as decontamination procedures, procedures for discarding contaminated needles and handling regulated wastes; and 4) use of protective equipment, such as gloves, gowns and masks that must be provided to employees free-of-charge.

The plan must be available to all employees. It must also be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new employee positions with occupational exposure. (See Appendix for Model Exposure Plan)

C. Employee Education

Employers must ensure that all employees with occupational exposure participate in a training program which must be provided at no cost to the employee and during work hours. Annual training must also be provided within one year of previous training.

D. Record-keeping

Employers must establish and maintain accurate records for each employee with occupational exposure. Records must include employee's name and social security number, copy of all results of examinations, medical testing and follow-up procedures. All medical records must be kept confidential.

4. Are there any penalties for non-compliance?

Yes. Non-compliance is subject to fines of up to $70,000 for a willful violation.

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.