Subchapter H. MANIFESTING FOR INFECTIOUS AND CHEMOTHERAPEUTIC WASTE


GENERAL

Sec.


284.701.    Scope.
284.702.    Transfer facilities.
284.703.    Recordkeeping.

GENERATOR RESPONSIBILITIES


284.711.    Use of manifest.
284.712.    Preparation of manifest.
284.713.    Generator’s distribution of copies.
284.714.    Exception reporting.

TRANSPORTER RESPONSIBILITIES


284.721.    Basic requirements.
284.722.    Preparation and use of manifest.
284.723.    Waste delivey.
284.724.    Transportation limitations.

FACILITY RESPONSIBILITIES


284.731.    Scope.
284.732.    Use of manifest.
284.733.    Distribution of copies.
284.734.    Significant discrepancies.

Cross References

   This subchapter cited in 25 Pa. Code §  284.2 (relating to permit-by-rule for infectious or chemotherapeutic waste processing facilities; qualifying facilities; general requirements); and 25 Pa. Code §  284.121 (relating to contents of general permits).

GENERAL


§ 284.701. 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.

Cross References

   This section cited in 25 Pa. Code §  284.2 (relating to permit-by-rule for infectious or chemotherapeutic waste processing facilities; qualifying facilities; general requirements); 25 Pa. Code §  284.602 (relating to license requirement); 25 Pa. Code §  284.721 (relating to basic requirements); and 25 Pa. Code §  284.732 (relating to use of manifest).

§ 284.702. Transfer facilities.

 (a)  Infectious or chemotherapeutic waste or processed infectious 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.

 (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.

§ 284.703. 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.

GENERATOR RESPONSIBILITIES


§ 284.711. 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.

§ 284.712. 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.

Cross References

   This section cited in 25 Pa. Code §  284.721 (relating to basic requirements).

§ 284.713. 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.

§ 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 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.

TRANSPORTER RESPONSIBILITIES


§ 284.721. 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).

§ 284.722. 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.

§ 284.723. 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.

§ 284.724. 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).

FACILITY RESPONSIBILITIES


§ 284.731. 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.

§ 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 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.

Cross References

   This section cited in 25 Pa. Code §  284.731 (relating to scope).

§ 284.733. 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.

Cross References

   This section cited in 25 Pa. Code §  284.731 (relating to scope).

§ 284.734. 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.

Cross References

   This section cited in 25 Pa. Code §  284.731 (relating to scope); and 25 Pa. Code §  284.732 (relating to use of manifest).



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