Subchapter H. TRACKING OF REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE
GENERAL Sec.
284.701. Scope.
284.702. Transfer facilities.
284.703. Recordkeeping.
GENERATOR RESPONSIBILITIES
284.711. Use of logs or shipping papers.
284.712. Preparation of logs or shipping papers.
284.713. [Reserved].
284.714. Exception reporting.
TRANSPORTER RESPONSIBILITIES
284.721. [Reserved].
284.722. Preparation and use of logs or shipping papers.
284.723. [Reserved].
284.724. Transportation limitations.
FACILITY RESPONSIBILITIES
284.731. Scope.
284.732. Use of logs or shipping papers.
284.733. [Reserved].
284.734. Significant discrepancies.
Cross References This subchapter cited in 25 Pa. Code § 284.2 (relating to permits-by-rule for regulated medical 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 subsection (b), this subchapter applies to a person or municipality that generates, transports, disposes or processes regulated medical or chemotherapeutic waste or processed 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 regulated medical or chemotherapeutic waste by generators.
(2) Onsite movement of regulated medical or chemotherapeutic waste by operators of permitted regulated medical or chemotherapeutic waste management facilities.
(3) Transportation by a generator who generates less than 220 pounds per month of regulated medical 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 log or shipping paper with the waste shipment to the offsite processing or disposal facility.
(4) The transportation of regulated medical 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 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:
(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 who generates and processes onsite less than 220 pounds per month of regulated medical or chemotherapeutic waste, 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:
(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.
(iii) A copy of the log or shipping paper shall be provided to the disposal facility by the transporter for each shipment of waste.
(6) The transportation through this Commonwealth of regulated medical or chemotherapeutic waste generated outside this Commonwealth that is destined for processing or disposal outside this Commonwealth.
(7) The transportation of processed regulated medical or chemotherapeutic waste to a disposal facility if the waste has been rendered unrecognizable.
Source The provisions of this § 284.701 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273328) to (273330).
Cross References This section cited in 25 Pa. Code § 284.2 (relating to permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements); 25 Pa. Code § 284.602 (relating to license requirement); and 25 Pa. Code § 284.732 (relating to use of logs or shipping papers).
§ 284.702. Transfer facilities.
Regulated medical waste, chemotherapeutic waste or processed regulated medical or chemotherapeutic waste that is recognizable may be transported to or from a transfer facility in accordance with the following:
(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.
(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 designated facility for purposes of this subchapter.
Source The provisions of this § 284.702 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273330).
§ 284.703. Recordkeeping.
The records required under this subchapter shall be retained for at least 2 years from the date on which the record was prepared. Records shall be submitted to the Department upon request. The retention period will be extended automatically during the course of an enforcement action or as requested by the Department.
Source The provisions of this § 284.703 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273330).
GENERATOR RESPONSIBILITIES
§ 284.711. Use of logs or shipping papers.
A generator who transports, or offers for transportation, regulated medical or chemotherapeutic waste for offsite processing or disposal shall ensure proper segregation of regulated medical and chemotherapeutic waste from other types of waste and prepare a log or shipping paper as required under this subchapter. A processor who transports, or offers for transportation, processed regulated medical or chemotherapeutic waste that is recognizable for offsite disposal shall be considered a generator for purposes of this subchapter.
Source The provisions of this § 284.711 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273330) to (273331).
§ 284.712. Preparation of logs or shipping papers.
(a) The generator shall create a log or shipping paper of the following information and provide it to the transporter before the offsite transportation of the waste occurs:
(1) The name, mailing address and telephone number of the generator.
(2) Each transporter’s company name, identification number, Pennsylvania regulated medical and chemotherapeutic waste transporter license number and telephone number.
(3) The number of containers, types of containers and the total quantity of the waste by weight or volume.
(4) One of the following regulated medical or chemotherapeutic waste code numbers for each waste type, as appropriate:
(i) A100 for regulated medical waste.
(ii) A200 for processed regulated medical waste that is recognizable.
(iii) A300 for chemotherapeutic waste.
(5) The United States Department of Transportation proper shipping name, hazard class and identification number (UN or NA) for each waste identified by 49 CFR Subtitle B, Chapter I, Subchapter C (relating to hazardous materials regulations), if applicable.
(6) Special instructions and information necessary for proper handling of the waste during transportation, processing, storage or disposal, if any.
(7) The printed or typed name and handwritten signature of the generator’s authorized representative, and the date of shipment.
(8) The printed or typed name and handwritten signature of the initial transporter’s authorized representative, and the date of receipt.
(b) An authorized representative of the generator shall ensure that a legible log or shipping paper has been completed.
(c) 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 logs or shipping papers).
Source The provisions of this § 284.712 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273331) to (273332).
§ 284.713. [Reserved].
Source The provisions of this § 284.713 reserved November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273333).
§ 284.714. Exception reporting.
(a) A generator that does not receive a 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 operator of the designated facility, or both, to determine the status of the shipment.
(2) Notify the Department’s appropriate regional office by telephone within 1 business day of the status of the shipment.
(b) If the generator has not received a 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 record of the waste 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.
Source The provisions of this § 284.714 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273333).
TRANSPORTER RESPONSIBILITIES
§ 284.721. [Reserved].
Source The provisions of this § 284.721 reserved November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273333).
§ 284.722. Preparation and use of logs or shipping papers.
(a) Before transporting regulated medical or chemotherapeutic waste or processed regulated medical or chemotherapeutic waste that is recognizable, the transporter shall provide the generator with a dated signature, including, but not limited to, handwritten, electronic or stamped signatures, from an authorized representative of the transporter acknowledging that the transporter has accepted the waste from the generator on the date of acceptance.
(b) The transporter shall ensure that the log or shipping paper required under subsections (c) and (d) accompanies the waste shipment.
(c) A transporter who delivers 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) The date that each container of waste was delivered to a designated facility.
(2) The name and address of the designated facility for each container of waste.
(d) The transporter who delivers regulated medical or chemotherapeutic waste to another transporter shall create a log or shipping paper containing the following information:
(1) The date that each container of waste was delivered to the subsequent transporter.
(2) The name and address of the subsequent transporter that received each container of waste.
(e) At the time the waste is delivered to the designated facility or subsequent transporter, the transporter shall provide the operator of the designated facility or subsequent transporter 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.
Source The provisions of this § 284.722 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273334).
Cross References This section cited in 25 Pa. Code § 284.712 (relating to preparation of logs or shipping papers).
§ 284.723. [Reserved].
Source The provisions of this § 284.723 reserved November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273334) to (273335).
§ 284.724. Transportation limitations.
(a) A transporter may not accept or transport a shipment of regulated medical or chemotherapeutic waste or processed 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 § 284.413 or § 284.512 (relating to storage containers; and transportation of regulated medical and chemotherapeutic waste; general provisions).
(2) The waste is not labeled or identified as required under § 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 in the generator’s log or shipping paper at the time of acceptance by the transporter.
(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).
Source The provisions of this § 284.724 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273335).
FACILITY RESPONSIBILITIES
§ 284.731. Scope.
Sections 284.732 and 284.734 (relating to use of logs or shipping papers; and significant discrepancies) apply to operators of waste processing or disposal facilities that receive regulated medical or chemotherapeutic waste or processed regulated medical or chemotherapeutic waste that is recognizable from offsite sources.
Source The provisions of this § 284.731 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273335).
§ 284.732. Use of logs or shipping papers.
(a) Except for waste managed in accordance with § 284.701 (relating to scope), an operator of a designated facility may not accept shipments of regulated medical or chemotherapeutic waste or processed regulated medical or chemotherapeutic waste that is recognizable from offsite sources unless the shipment is accompanied by a log or shipping paper as required under this subchapter.
(b) The operator of the designated facility shall:
(1) Examine the records of the transporter.
(2) Note significant discrepancies in the log or shipping paper of the generator and transporter, as defined in § 284.734 (relating to significant discrepancies).
(3) Provide the transporter with a dated signature, including, but not limited to, handwritten, electronic or stamped signatures, from an authorized representative of the facility, acknowledging that it has accepted the waste from the transporter on that date.
Source The provisions of this § 284.732 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273335) to (273336).
Cross References This section cited in 25 Pa. Code § 284.731 (relating to scope).
§ 284.733. [Reserved].
Source The provisions of this § 284.733 reserved November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273336).
§ 284.734. Significant discrepancies.
(a) This section applies if there is a significant discrepancy in the logs or shipping papers of the generator and transporter. A discrepancy is a difference between the quantity or type of waste designated 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:
(1) There is a variation greater than 5% in weight, for bulk waste.
(2) There is a variation in piece count, for batch waste, excluding 1% variation for generator-loaded trailers.
(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 the logs or shipping papers, the 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 operator shall immediately notify the appropriate regional office of the Department by telephone. Within 7 business days of receipt of the waste, the operator shall also send a letter to the regional office describing the discrepancy and attempts to reconcile it.
Source The provisions of this § 284.734 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273336) to (273337).
Cross References This section cited in 25 Pa. Code § 284.731 (relating to scope); and 25 Pa. Code § 284.732 (relating to use of logs or shipping papers).
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