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Pennsylvania Code



Subchapter G. TRANSPORTER LICENSING FOR REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE


GENERAL PROVISIONS

Sec.


284.601.    Scope.
284.602.    License requirement.
284.603.    Identification number.

LICENSE APPLICATION REQUIREMENTS


284.611.    General application requirements.
284.612.    Vehicular liability insurance.

LICENSE APPLICATION REVIEW


284.621.    Criteria for license issuance or denial
284.622.    Term of license.
284.623.    Conditions of licenses.
284.624.    License renewal.
284.625.    Public notice.

OPERATIONAL REQUIREMENTS


284.631.    Basic limitations.
284.632.    Regulated medical or chemotherapeutic waste discharges or spills.
284.633.    Safety.
284.634.    Annual report.

BOND


284.641.    Bond requirement.
284.642.    Release of bond.
284.643.    Bond forfeiture.
284.644.    Replacement of existing bond.
284.645.    Preservation of remedies.

Cross References

   This subchapter cited in 25 Pa. Code §  284.121 (relating to contents of general permits).

GENERAL PROVISIONS


§ 284.601. Scope.

 This subchapter sets forth the Department’s requirements for licensing of persons and municipalities that transport regulated medical or chemotherapeutic waste.

Source

   The provisions of this §  284.601 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273318).

§ 284.602. License requirement.

 (a)  Except as provided in subsection (b), a person or municipality may not transport regulated medical or chemotherapeutic waste unless the person has first obtained a license from the Department in accordance with this subchapter.

 (b)  This subchapter does not apply to the following:

   (1)  Onsite movement of 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 of less than 220 pounds per month of regulated medical or chemotherapeutic waste when transporting only the generator’s own regulated medical or chemotherapeutic waste if the log and shipping paper requirements under §  284.701(b)(3) (relating to scope) are met.

   (4)  The transportation of regulated medical or chemotherapeutic waste generated outside this Commonwealth destined for processing or disposal outside this Commonwealth.

Source

   The provisions of this §  284.602 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273318).

§ 284.603. Identification number.

 A person or municipality subject to this chapter may not transport regulated medical or chemotherapeutic waste without first receiving an identification number. The number shall be one of the following:

   (1)  An EPA identification number obtained under section 3010 of the Resource Conservation and Recovery Act of 1976 (42 U.S.C.A. §  6930).

   (2)  An identification number obtained from the Department if the identification number under paragraph (1) is not available.

Source

   The provisions of this §  284.603 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273319).

Cross References

   This section cited in 25 Pa. Code §  284.611 (relating to general application requirements).

LICENSE APPLICATION REQUIREMENTS


§ 284.611. General application requirements.

 (a)  An application for a license to transport regulated medical or chemotherapeutic waste shall be submitted to the Department, in writing, on forms provided by the Department. An application for a license shall be accompanied by information, specifications and other data required by the Department to determine compliance with this subchapter.

 (b)  The application shall contain the following:

   (1)  The applicant’s identification number, as required under §  284.603 (relating to identification number).

   (2)  The name, mailing address, place of business, business telephone number and 24-hour emergency telephone number of the applicant.

   (3)  The average yearly total tonnage of regulated medical and chemotherapeutic waste picked up or delivered in this Commonwealth.

   (4)  A nonrefundable application fee in the form of a check payable to the ‘‘Commonwealth of Pennsylvania’’ for $500.

   (5)  Information concerning terminal locations that will store regulated medical and chemotherapeutic waste in-transit.

   (6)  An identification of interests and compliance history, as provided in § §  271.124 and 271.125 (relating to identification of interests; and compliance information).

   (7)  Collateral bond, as required under §  284.641 (relating to bond requirement).

   (8)  Certificate of insurance, as required under §  284.612 (relating to vehicular liability insurance).

   (9)  A contingency plan consistent with §  284.632 (relating to regulated medical or chemotherapeutic waste discharges or spills).

 (c)  An application for a license shall be certified by a responsible official of the applicant with a statement that the information contained in the application is true and correct to the best of the official’s information and belief.

Source

   The provisions of this §  284.611 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273319) to (273320).

§ 284.612. Vehicular liability insurance.

 (a)  The application shall include a certificate of insurance issued by an insurance company authorized to do business in this Commonwealth, certifying that the applicant has comprehensive vehicular liability insurance in force covering the operation of vehicles and associated regulated medical and chemotherapeutic waste transportation activities.

 (b)  The certificate of insurance shall expressly document coverage for property damage and bodily injury to third parties. The insurance coverage shall include coverage for the cost of cleaning up a regulated medical or chemotherapeutic waste spill, and damages arising from the spill. Minimum insurance coverage shall be $500,000 annual aggregate, exclusive of claims administration and legal defense costs.

 (c)  Insurance coverage provided under this section shall comply with the following:

   (1)  The insurance policy shall follow the standard commercial or comprehensive vehicular liability policy forms approved by the Insurance Department, and shall include coverage as specified in subsections (a) and (b).

   (2)  The insurance policy shall be issued by an insurer having a certificate of authority and a licensed agent authorized to transact the business of insurance in this Commonwealth by the Insurance Department. Insurance may be provided by an excess or surplus lines insurer approved by the Insurance Department.

   (3)  The full policy amount shall be applicable to each driver and vehicle authorized to operate under the license. There may be no proration of the policy amount of coverage among vehicles.

   (4)  The insurance policy shall provide that the insurer shall notify the Department by certified mail within 30 days whenever a substantive change is made in the policy, including policy amounts, scope of coverage, tail period, claims procedures, definitions of occurrences or claims, or other provisions related to the requirements of this subchapter.

 (d)  The licensee shall maintain the insurance required by this section in full force and effect during the term of the license and renewals thereof.

 (e)  An applicant for a transporter license to transport regulated medical or chemotherapeutic waste which is a department or an agency of the United States or of the Commonwealth may fulfill the requirements under this section by means of one or more of the following:

   (1)  Commercial insurance as specified in this section.

   (2)  Self-insurance allowed by Federal or State law.

   (3)  Additional means approved by the Department.

 (f)  The amount of liability coverage for departments or agencies of the Commonwealth may not exceed the liability limits of 42 Pa.C.S. Chapter 85 (relating to matters affecting government units).

Source

   The provisions of this §  284.612 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273320) to (273321).

Cross References

   This section cited in 25 Pa. Code §  284.611 (relating to general application requirements).

LICENSE APPLICATION REVIEW


§ 284.621. Criteria for license issuance or denial.

 (a)  A license application will not be approved unless the applicant affirmatively demonstrates to the Department’s satisfaction that the following conditions are met:

   (1)  The license application is complete and accurate.

   (2)  The requirements of the act, the environmental protection acts and this title have been complied with.

   (3)  The compliance status of the applicant or a related party under section 503(c) and (d) of the act (35 P. S. §  6018.503(c) and (d)) does not require or allow license denial.

 (b)  The Department will deny a license application if the applicant fails to provide the Department with a bond consistent with this subchapter or fails to provide other required information within 120 days after the Department’s written request.

§ 284.622. Term of license.

 A license granted or renewed under this subchapter is valid for 2 years unless the Department determines that circumstances justify issuing a license for less than 2 years. The expiration date will be set forth in the license.

Cross References

   This section cited in 25 Pa. Code §  284.624 (relating to license renewal).

§ 284.623. Conditions of licenses.

 (a)  The Department may place terms and conditions upon a license it deems necessary to protect public health, public safety and the environment, and to ensure compliance with the act, the environmental protection acts and this title.

 (b)  Except to the extent that the license states otherwise, the licensee shall conduct transportation activities as described in the approved application.

 (c)  A license to transport regulated medical and chemotherapeutic waste is nontransferable and nonassignable. A license applies to the licensee and its employees. Leased or subcontracted haulers, and haulers who provide equipment, have no authority to operate under the licensee’s license without prior written approval from the Department.

Source

   The provisions of this §  284.623 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273321) to (273322).

§ 284.624. License renewal.

 A licensee that plans to transport regulated medical or chemotherapeutic waste after expiration of the current license term under §  284.622 (relating to term of license) shall file a complete application for license renewal on forms provided by the Department at least 90 days before the expiration date of the license. The application shall include a nonrefundable application fee in the form of a check payable to the ‘‘Commonwealth of Pennsylvania’’ for $500. The license renewal application will be reviewed by the Department in the same manner as a new application for a license under this subchapter.

Source

   The provisions of this §  284.624 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273322).

§ 284.625. Public notice.

 The Department will publish notice in the Pennsylvania Bulletin of the following:

   (1)  Receipt of an application for a license under this subchapter.

   (2)  Approval or denial of a license application under this subchapter.

OPERATIONAL REQUIREMENTS


§ 284.631. Basic limitations.

 (a)  A person or municipality subject to this subchapter that transports regulated medical or chemotherapeutic waste shall comply with the following:

   (1)  The act, this article and other applicable regulations promulgated under the act, including Subchapter F (relating to collection and transportation).

   (2)  The terms and conditions of the license, the environmental protection acts, this title and orders issued by the Department.

 (b)  A transporter shall allow authorized representatives of the Commonwealth, without advance notice or a search warrant, upon presentation of appropriate credentials, and without delay, to have access to areas in which operations will be, are being or have been conducted.

Source

   The provisions of this §  284.631 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273322).

§ 284.632. Regulated medical or chemotherapeutic waste discharges or spills.

 (a)  A copy of the most recently approved Transporter Contingency Plan (TCP) shall be carried on each transport vehicle at all times. Information in the TCP shall be kept current.

 (b)  In the event of a discharge or spill of regulated medical or chemotherapeutic waste during transportation, the transporter shall take appropriate immediate action to protect the health and safety of the public and the environment, in accordance with its approved TCP. The transporter shall also immediately telephone the Department and the affected municipality, and provide the following information:

   (1)  The name of the person reporting the spill or discharge.

   (2)  The transporter’s name, address, the Department-issued regulated medical and chemotherapeutic waste transporter license number and identification number.

   (3)  The telephone number where the person reporting the spill or discharge can be reached.

   (4)  The date, time and location of the spill or discharge.

   (5)  The mode of transportation and type of transport vehicle.

   (6)  A brief description of the accident.

   (7)  For each waste involved in the spill:

     (i)   The name and identification number of the generators of the waste.

     (ii)   The estimated quantity of the waste spilled.

 (c)  If a discharge or spill of regulated medical or chemotherapeutic waste occurs during transportation, and if the immediate removal of the waste is necessary to protect public health and safety or the environment, the Department may authorize the removal of the waste to a selected receiving facility by transporters who do not have identification numbers, licenses, logs or shipping papers under this subchapter.

 (d)  A transporter shall:

   (1)  Clean up a regulated medical or chemotherapeutic waste discharge or spill that occurs during transportation or take action that may be required or approved by the Department so that the discharge or spill no longer presents a hazard to public health, public safety or the environment.

   (2)  File a complete report in writing concerning the incident with the Department’s Central Office. The report shall include, at a minimum, a detailed description of the clean-up operation and the disposition of the waste, and the information required by subsection (a).

Source

   The provisions of this §  284.632 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273322) to (273323).

Cross References

   This section cited in 25 Pa. Code §  284.611 (relating to general application requirements); and 25 Pa. Code §  284.633 (relating to safety).

§ 284.633. Safety.

 A transporter of regulated medical or chemotherapeutic waste shall provide adequate personnel training to ensure transport activities are conducted safely, in compliance with applicable laws and regulations, and according to the contingency plan approved under §  284.632 (relating to regulated medical or chemotherapeutic waste discharges or spills).

Source

   The provisions of this §  284.633 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273323).

§ 284.634. Annual report.

 (a)  A transporter shall submit to the Department’s Central Office an annual report. The report shall be submitted by the end of March of each calendar year. The report shall be submitted on forms supplied by the Department.

 (b)  The annual report shall be based on the shipments of regulated medical or chemotherapeutic waste during the previous calendar year, and shall include the following:

   (1)  The name, location, telephone number and permit identification number of each processing or disposal facility to which the transporter delivered regulated medical or chemotherapeutic waste.

   (2)  The weight or volume of each type of regulated medical or chemotherapeutic waste transported.

   (3)  When more than one transporter is used to transport a single shipment of regulated medical or chemotherapeutic waste from the generator to the processing or disposal facility, only the first transporter is required to submit information for that shipment on the annual report.

Source

   The provisions of this §  284.634 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273324).

BOND


§ 284.641. Bond requirement.

 (a)  General. The applicant shall provide the Department a bond, secured by collateral as specified by this section and which bond is conditional upon compliance by the licensee with the requirements of the act, the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. § §  6019.1—6019.6), known as the Infectious and Chemotherapeutic Waste Law, regulations thereunder, the terms and conditions of the license and Department orders issued to the licensee. The bond shall be consistent with, and subject to, the requirements of this section. The amount, duration, form, conditions and terms of the bond will be specified by the Department. An additional bond amount will not be required of applicants that are also licensed hazardous waste transporters during the term of license or renewal thereof under this subchapter if the applicant or licensee submits a bond endorsement, including an increase in the amount of the bond of a minimum of $10,000, to the Department that includes liability for regulated medical and chemotherapeutic waste transportation on the hazardous waste transporter bond.

 (b)  Approval by Department. A license to transport regulated medical or chemotherapeutic waste will not be issued by the Department before the applicant for the license has filed a collateral bond payable to the Department on a form provided by the Department, and the bond has been approved by the Department.

 (c)  Amount of bond.

   (1)  The bond shall be in an amount sufficient to assure that the licensee faithfully performs the requirements of the act, the Infectious and Chemotherapeutic Waste Law and regulations thereunder, the terms and conditions of the license, and Department orders issued to the licensee. The minimum amount of the bond is $10,000.

   (2)  The Department may require additional bond amounts if the mode of transporting waste changes, or the Department determines additional bond amounts are necessary to meet the requirements described in paragraph (1).

 (d)  Term of bond. Liability under the bond shall contain at a minimum for the duration of the license, any renewals thereof and for 1 year after expiration, termination, revocation or surrender of the license. The 1-year extended period of liability includes, and shall be automatically extended for, an additional time period during which administrative or legal proceedings are pending involving a violation by the transporter of the act, the Infectious and Chemotherapeutic Waste Law, regulations thereunder, the terms and conditions of the license or Department orders issued to the licensee.

 (e)  Collateral for transporter bonds.

   (1)  The Department will accept the types of collateral for transporter bonds that are provided in §  271.322 (relating to general terms and conditions for collateral bonds).

   (2)  The terms and conditions for the bonds shall be as provided in § §  271.322—271.325.

   (3)  A department or agency of the United States or the Commonwealth applying for a transporter license to transport regulated medical or chemotherapeutic waste shall satisfy the requirements of this section by filing a bond with the Department under this section, or by another means of financial assurance approved by the Department which satisfies the terms and conditions for bonds under §  271.313(b) (relating to forms, terms and conditions of the bond or trust). The Department may accept a bond executed by a transporter who is not the licensee, instead of a bond executed by the licensee, if the liability on the bond meets the requirements of this subchapter. The transporter may not accept waste or initiate operation prior to the approval by the Department of the financial assurances required by this section.

 (f)  Review of bonds. Bonds will be reviewed for legality and form according to established Department procedures.

Source

   The provisions of this §  284.641 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273324) to (273325).

Cross References

   This section cited in 25 Pa. Code §  284.611 (relating to general application requirements).

§ 284.642. Release of bond.

 (a)  Except as provided in subsection (b), the Department will release a transporter bond 1 year after the expiration or termination of a license upon written request of the licensee.

 (b)  The Department will not release a bond if the transporter is in violation of the act, the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. § §  6019.1—6019.6), known as the Infectious and Chemotherapeutic Waste Law, regulations thereunder, the terms and conditions of the license or Department orders issued to the licensee, whether or not the violation results from regulated medical or chemotherapeutic waste transportation.

 (c)  The release of a bond by the Department does not constitute a waiver or release of other liability provided in law, nor does it abridge or alter rights of action or remedies of a person or municipality presently or prospectively existing in equity or under criminal and civil common or statutory law.

Source

   The provisions of this §  284.642 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273325) to (273326).

Cross References

   This section cited in 25 Pa. Code §  284.644 (relating to replacement of existing bond).

§ 284.643. Bond forfeiture.

 (a)  The Department will declare a bond forfeit if the transporter is in violation of the act, the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. § §  6019.1—6019.6), known as the Infectious and Chemotherapeutic Waste Law, regulations thereunder, the terms and conditions of the bond, the terms and conditions of the license or Department orders issued to the licensee, whether or not the violation results from regulated medical or chemotherapeutic waste transportation.

 (b)  If the Department declares a bond forfeit, it will:

   (1)  Send written notification to the transporter of the Department’s determination to declare the bond forfeit and the reasons for the forfeiture.

   (2)  Advise the transporter and surety of the right to appeal to the EHB under the Environmental Hearing Board Act (35 P. S. § §  7511—7516).

   (3)  Proceed to collect on the bond as provided by applicable laws for the collection of defaulted bonds or other debts.

 (c)  If the Department declares a transporter bond forfeited, it will pay, or direct the State Treasurer to pay, the collateral funds into the Solid Waste Abatement Fund. If upon proper demand and presentation, the banking institution or other person or municipality which issued the collateral refuses to pay the Department the proceeds of a collateral undertaking, the Department will take appropriate steps to collect the proceeds.

Source

   The provisions of this §  284.643 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273326).

§ 284.644. Replacement of existing bond.

 (a)  The Department may allow a transporter to replace an existing collateral bond with another collateral bond, if the liability which has accrued under the bond and against the transporter is incorporated into the replacement bond. The bond amount for this replacement bond will be determined under this subchapter, but may not be less than the amount of the existing bond.

 (b)  The Department will not release existing bonds until the transporter has submitted and the Department has approved acceptable replacement bonds. A replacement of bonds under this section does not constitute a release of bond under §  284.642 (relating to release of bond).

§ 284.645. Preservation of remedies.

 Remedies provided or authorized by law for violation of statutes, including, but not limited to, the act, the applicable environmental protection acts, this title and the terms and conditions of permits or licenses, and orders of the Department, are expressly preserved. Nothing in this subchapter is an exclusive penalty or remedy for the violations. No action taken under this subchapter waives or impairs another remedy or penalty provided in law or equity.



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