Document Citation: CRIR 12-030-017

Header:

CODE OF RHODE ISLAND RULES
AGENCY 12. DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
SUB-AGENCY 030. OFFICE OF WASTE MANAGEMENT
CHAPTER 017. GENERATION, TRANSPORTATION, STORAGE, TREATMENT, MANAGEMENT AND DISPOSALOF REGULATED MEDICAL WASTE IN RHODE ISLAND

Date:
08/31/2009

Document:
12 030 017. GENERATION, TRANSPORTATION, STORAGE, TREATMENT, MANAGEMENT AND DISPOSALOF REGULATED MEDICAL WASTE IN RHODE ISLAND

14.2 Regulated Medical Waste Transporter Permit Requirements

(a) Exemption: The requirements of this Section shall not be applicable to use of vehicles to collect and transport regulated medical waste in emergency situations which present a threat to public health and safety. In the event of an emergency, the Director shall be immediately notified of each vehicle used for the cleanup and transportation of regulated medical waste. Notwithstanding this exemption, all collected regulated medical waste shall be managed in accordance with all applicable regulations at all times subsequent to this notification.

(b) Contents of Application: A transporter shall submit an application for a Regulated Medical Waste Transporter Permit on a form prescribed by the Director. Such application shall include, as a minimum, the following:

(1) Name under which the application is being made;

(2) Applicant's business location(s) and mailing address if different from business location(s);

(3) Applicant's business phone number;

(4) Name, address and phone number of the owner of the applicant company;

(5) The name(s), address(es) and phone number(s) of the applicant's personnel who can be reached in case of an emergency;

(6) The name(s) and signature(s) of all company personnel who are authorized to sign medical waste tracking forms;

(7) A list of all employees authorized to transport or otherwise handle Regulated Medical Waste and a certification that these employees have been trained in the hazards of blood borne pathogens. This list must be amended when new individuals are hired.

(8) The following information for each vehicle that may be used to transport regulated medical waste:

(i) The manufacturer;

(ii) Model;

(iii) Year of manufacture;

(iv) Vehicle Identification Number (VIN);

(v) Cargo-carrying capacity;

(vi) Proof of ownership of each vehicle; and

(vii) Proof of current registration for each vehicle with the appropriate state motor vehicle agency;

(9) The address of any transfer station(s) and/or vehicle parking area(s) used by the applicant for storing or parking vehicles identified in Section 14.2(b)(7) of these regulations;

(10) Location(s) to be used, pursuant to Section 14.11 of these regulations, for temporary storage of regulated medical waste in vehicles;

(11) The specific location(s) and/or person(s) to which the transporter delivers or intends to deliver regulated medical waste, and a signed notarized statement from each person and/or location which certifies that said person/location is in compliance with all applicable licensing/permitting requirements for the jurisdiction(s) to which regulated medical waste will be transported;

(12) A copy of the applicant's Spill Management Plan prepared in accordance with the requirements of Section 14.7 of these regulations;

(13) The permit application fee specified by Section 14.2(f)(1) of these regulations;

(14) The signature of the applicant or a person duly authorized to act on behalf of the applicant; and

(15) Any other information reasonably required by the Director to demonstrate that the applicant can safely transport regulated medical waste and comply with all applicable provisions of Section 14.0 of these regulations.

(c) Notification of Changes: A transporter who has been issued a Regulated Medical Waste Transporter Permit shall notify the Director, in writing, of any change(s) in the information required by the permit application. Such notification shall be provided in advance whenever possible. However, in no case shall the notification be postmarked later than five (5) business days after the effective date of the change(s). Notwithstanding the foregoing, the Director shall be notified, in writing, of the name(s) and signature(s) of additional company personnel authorized to sign medical waste tracking forms before the employee(s) may sign the tracking forms.

(d) Vehicle Requirements

(1) Vehicles used to transport regulated medical waste in Rhode Island shall, as a minimum, meet the following requirements:

(i) The vehicle shall have a fully enclosed, leak-resistant cargo-carrying body;

(ii) The transporter shall maintain the cargo-carrying body in good sanitary condition;

(iii) The cargo-carrying body shall be secured if left unattended; and

(iv) The regulated medical waste shall not be subject to mechanical stress or compaction during loading and unloading or during transit;

(2) Vehicles used to transport regulated medical waste shall have the following identification in letters no less than three (3) inches in height on both sides and the back of the cargo-carrying body:

(i) The name of the transporter;

(ii) The transporter's Regulated Medical Waste Transporter Permit number; and

(iii) A universal biohazard sign or the following words imprinted:

(A) MEDICAL WASTE; or

(B) REGULATED MEDICAL WASTE;

(3) A transporter shall not transport regulated medical waste in the same container with other solid waste unless the transporter manages both as regulated medical waste in compliance with these regulations; and

(4) The transporter shall not use the cargo-carrying compartment of the vehicle to transport anything except regulated medical waste. Hazardous waste may be transported with regulated medical waste if the following criteria are met:

(i) The transporter vehicle is permitted to carry hazardous waste;

(ii) The regulated medical waste and the hazardous waste are packaged separately;

(iii) The hazardous waste is properly labeled, marked, packaged, and handled in accordance with all applicable laws and regulations; and

(iv) The transporter vehicle is identified, in accordance with all applicable regulations, as carrying both regulated medical waste and hazardous waste.

(e) Vehicle Inspection Requirements: Each vehicle identified in Section 14.2(d) of these regulations shall be inspected by the applicant prior to application for a Medical Waste Transporter Permit or application to add an additional vehicle to an existing permit. The applicant must complete the Department's vehicle checklist certifying the vehicle meets the Department's standards prior to the permitting of any vehicles. All equipment listed in the checklist shall be kept on the vehicle at all times.

(f) Regulated Medical Waste Transporter Permit Fees: Pursuant to Section 23-19.12-9 of the General Laws of Rhode Island, as amended, the Director has established the following fee schedule for Regulated Medical Waste Transporter Permits:

(1) A permit application fee of one hundred dollars ($ 125) per vehicle identified on the permit application;

(2) An annual registration fee of ($ 125) per vehicle, or a monthly fee of ($ 25) per vehicle identified on the permit application or on subsequent amendments;

(3) No permit fee adjustments shall be made for vehicles that are removed from the permit and not replaced.

(4) In the case of a tractor/trailer combination, the power unit (tractor) is the vehicle that is required to have a permit. The non-powered unit (trailer) is not required to possess a permit.

(g) Insurance: The holder of a Regulated Medical Waste Transporter Permit shall maintain liability insurance sufficient to provide coverage of one million dollars ($ 1,000,000.00) per incident involving the transport of regulated medical waste.

(h) Expiration of Regulated Medical Waste Transporter Permits: Upon approval by the Director, a Regulated Medical Waste Company's Registration shall expire three (3) years from the date of issuance, unless sooner modified, suspended or revoked. However, the transporter permits shall expire annually and the transporter must pay the annual registration fee of $ 100 for each vehicle that carries waste.

(i) Renewal of Regulated Medical Waste Transporter Permits

(1) Requests for renewal of a Regulated Medical Waste Transporter Permit shall contain all the information required by Section 14.2 of these regulations without reference to any previously submitted material.

(2) In any case in which a holder of a Regulated Medical Waste Transporter Permit has filed an application in proper form for renewal not less than thirty (30) days prior to expiration of his/her existing permit, the existing permit shall not expire until final action on the application has been taken by the Director.

14.3 Accepting Regulated Medical Waste for Transport

(a) Transporters shall not accept for transport within Rhode Island any regulated medical waste unless the regulated medical waste is packaged in accordance with Section 7.0 of these regulations and Labeled/Marked in accordance with Section 11.0 of these regulations.

(b) Transporters shall not accept regulated medical waste for transport within Rhode Island unless it is accompanied by a properly completed tracking form as required under Section 13.3 of these regulations unless the generator is exempt from the use of the tracking form under Section 13.2 of these regulations.

(c) Notwithstanding Section 14.3(b) of these regulations, a non-rail transporter may accept from a rail transporter regulated medical waste that is not accompanied by a tracking form, provided that such non-rail transporter:

(1) Signs and dates all copies of the medical waste tracking form which has been forwarded by the generator or the first non-rail transporter to the accepting non-rail transporter, or, if the tracking form has not been received by the accepting non-rail transporter, on the shipping paper;

(2) Leaves a copy of the signed and dated shipping paper with the rail transporter, if applicable; and

(3) Retains a copy of the signed and dated shipping paper or tracking form, as applicable.

(d) Before accepting regulated medical waste that is accompanied by a tracking form, a transporter shall:

(1) Verify that the tracking form accurately reflects the number of containers and quantity of all treated and untreated regulated medical waste accepted;

(2) On all copies of the tracking form, sign and indicate the date the waste was accepted from the generator or prior transporter, as applicable; and

(3) If the transporter is the first transporter of the waste, return a copy of the signed and dated tracking form to the generator before accepting the waste, or if the transporter is a subsequent transporter of the waste, return a copy of the signed and dated tracking form to the prior transporter before accepting the waste; and

(4) Return a signed copy of the tracking form to the generator before leaving the generator's site.

(5) Retain one copy of the signed and dated tracking form.



14.7 Management of Spills

(a) Spill Management Plan: All transporters, intermediate handlers, and destruction facilities shall adopt and adhere to a written procedure developed by the transporter and approved by the Department, to govern the management and decontamination of regulated medical waste spills.

(b) Cleanup Equipment and Supplies: All transporters, intermediate handlers, and destruction facilities shall have at each site, including each vehicle used to transport regulated medical waste, appropriate equipment and supplies for cleaning up a spill of regulated medical waste. Equipment and supplies shall include, but are not limited to, the following:

(1) Spill Containment and Cleanup Kit: A spill containment and cleanup kit shall be kept in each area utilized for the collection, transfer, storage, treatment, packaging or other such handling of regulated medical wastes. All vehicles operating under a Rhode Island Regulated Medical Waste Transporter Permit shall carry a spill containment and cleanup kit in the vehicle whenever regulated medical waste is transported. Personnel shall be trained in the use of the kit and the kit shall contain at least the following items:

(i) Absorbent material for spilled liquids. The absorbent material shall have a rated capacity of one gallon of liquid for every cubic foot of regulated medical waste that is normally managed in that area for which the kit is provided or ten (10) gallons, whichever is less;

(ii) One gallon of disinfectant in a sprayer capable of dispersing its charge in a mist and in a stream. The disinfectant shall be of hospital grade and of a formulation described in Section 14.7(c) of these regulations and be effective against mycobacteria;

(iii) Fifty (50) plastic infectious waste bags that meet the requirements of Section 7.5 of these regulations, accompanied by sealing tape (or devices for sealing), and appropriate labels as required by Section 11.0 of these regulations. These bags shall be large enough to overpack any box or other container normally used for regulated medical waste handling by the facility;

(iv) Two (2) sets of overalls, gloves, boots, caps and protective eye covering, all of which shall be disposable and impermeable to liquids. Overalls, boots and caps shall be oversized or fitted to medical waste handlers and be made of a moisture resistant or moisture proof material. Gloves for handling regulated medical waste where sharps are not present shall be durable and moisture resistant or moisture proof. Gloves for handling sharps shall be puncture resistant or puncture proof in addition to liquid resistant. Boots shall be of durable moisture resistant or moisture proof material, which will not tear under the stress of walking. At a minimum, protective-breathing devices shall include surgical masks. The kit shall also contain tape for sealing wrists and ankles;

(v) Scoop shovels, push brooms, and buckets;

(vi) A first-aid kit, fire extinguisher, lights, and other appropriate safety equipment;

(vii) A suitable means of communication for summoning aid in an emergency; and

(viii) An approved copy of the Spill Management Plan as described in Section 14.7 of these regulations.

(c) Disinfectants and Decontamination Procedures

(1) Approved routine decontamination procedures for soiled surfaces include, but are not limited to:

(i) Exposure to hot water of at least 82 [o ]C (180 [o ]F) for a minimum fifteen (15) seconds; or

(ii) Rinsing with or immersion in a chemical disinfectant; or

(iii) Rinsing with or immersion in a one-to-ten ( 1:10 ) dilution of five percent (5%) sodium hypochlorite solution.

(2) Any chemical disinfectant used for decontamination shall be registered with the U.S. EPA as hospital disinfectants that are tuberculocidal, fungicidal, virucidal and effective against HIV-1.

(d) The transporter shall make provisions for prompt control of spills and other emergencies, as set forth in the Spill Management Plan required by Section 14.7(a) of these regulations.

(e) Reporting of Medical Waste Spills

(1) In the event of a spill of regulated medical waste by the transporter, the transporter shall notify the Department immediately of the spill. In all cases of spills, the transporter shall immediately take steps to contain and clean up the regulated medical waste.

(2) In addition to the immediate notification requirement of Section 14.7(e)(1) of these regulations, the transporter shall, within forty-eight (48) hours of a spill of regulated medical waste, submit an accident report to the Director. A copy of the report shall be kept on file for a minimum of three (3) years at the same location as the Regulated Medical Waste Transporter Permit. The three (3) year period for retention shall start from the date of report. Record retention periods shall be extended during the course of any unresolved litigation, or when so requested by the Director or by EPA.

14.8 Other Inspections and Department Actions

Upon request of the Department, a medical waste transporter shall:

(a) Permit the Department to inspect Tracking forms, shipment logs, reports, permits, licenses, billing records, or other documents related to the transportation or other handling of regulated medical waste.

(b) Permit the Department to inspect any vehicle or related equipment or any vehicle parking area used by the transporter involved in the handling, transporting, storing or transferring regulated medical waste.

(c) Decontaminate, utilizing procedures described in Section 14.7 of these regulations, or permit the Department to decontaminate at the owner's expense, any vehicle or section of a facility that has been in contact with regulated medical waste, or take or allow the Department to take any other measures necessary to make such vehicle or facility safe.



15.2 Requirements for Treatment, Destruction, and Destination Facilities

(a) A treatment, destruction, or destination facility shall not accept regulated medical waste which is not packaged, labeled, and marked in accordance with Sections 7.0 and 11.0 of these regulations.

(b) A treatment, destruction or destination facility shall not accept regulated medical waste that is not accompanied by a tracking form that complies with Sections 13.0 and 14.0 of these regulations.

(c) No person shall operate a treatment, destruction, or destination facility at which regulated medical waste is burned or otherwise treated and/or destroyed unless such treatment, destruction, or destination facility complies with all applicable laws and regulations.

(d) All treatment, destruction, or destination facilities shall keep a spill containment and cleanup kit in or near any storage area, loading and unloading area, decontamination area, and treatment area where regulated medical waste is managed. The location of the kits shall provide for rapid and efficient cleanup of spills anywhere within these areas. The kit shall consist of at least the following items:

(1) Absorbent material for spilled liquids. The absorbent material shall have a rated capacity of one gallon of liquid for every cubic foot of regulated medical waste that is normally managed in the area for which the kit is provided or ten (10) gallons, whichever is less.

(2) One gallon of disinfectant in a sprayer capable of dispersing its charge in a mist and in a stream. The disinfectant shall be of hospital grade and of a formulation described in Section 14.7(c) of these regulations and be effective against mycobacteria.

(3) Fifty (50) red plastic infectious waste bags that meet the requirements of Section 7.5(c) of these regulations, accompanied by sealing tape (or devices), and appropriate labels as required by section 11.0 of these regulations. These bags shall be large enough to overpack any box or other container normally used for regulated medical waste handling by the facility.

(4) Two (2) sets of overalls, gloves, boots, caps and protective eye covering, all of which shall be disposable and be impermeable to liquids. Overalls, boots and caps shall be oversized or fitted to medical wastes workers and be made of a moisture resistant or moisture proof material. Gloves for handling regulated medical waste where sharps are not present shall be durable and of moisture resistant or moisture proof material. Gloves for handling sharps shall be puncture resistant or puncture proof in addition to liquid resistant. Boots shall be of durable moisture resistant or moisture proof material which will not tear under the stress of walking. Minimum protective breathing devices shall be surgical masks. Tape for sealing wrists and ankles shall also be provided in the kit.

(5) A first aid kit (unless emergency medical care is available on the premises), fire extinguisher, and other appropriate safety equipment.

(e) The disinfectants used in cleaning up a spill shall be registered with the U.S. EPA as hospital disinfectants that are also tuberculocidal, fungicidal, virucidal and effective against HIV-1. Also approved as a disinfectant is one-to-ten ( 1:10 ) dilution of five percent (5%) sodium hypochlorite solution.

(f) All regulated medical waste treatment, destruction, or destination facilities shall, at a minimum, implement the following procedures subsequent to a spill of regulated medical waste upon its discovery:

(1) The cleanup crew shall utilize the protective equipment described in Section 14.7 of these regulations during the spill cleanup operation;

(2) Limit access to the spill area only to authorized personnel;

(3) Place broken containers and spillage inside overpack bags in the kit.

(4) Disinfect the area and take other cleanup steps deemed necessary. Any absorbent materials used to disinfect the area shall be considered regulated medical waste;

(5) Clean and disinfect non-disposable items;

(6) Remove protective equipment and manage disposal items as regulated medical waste;

(7) Take necessary steps to replenish containment and cleanup kit;

(8) Call for emergency assistance if necessary;

(9) Report to the Director immediately all regulated medical waste spills or accidents, unless the quantity of such spills is less than one cubic foot of waste.

(10) Submit a medical waste spill report to the Director within forty-eight hours, using the spill or accident report form prescribed by the Director. Any regulated medical waste spill outside the limited access areas shall be reported to the Director. A copy of the report shall be on file at the treatment facility for a minimum of three (3) years. The report form shall include, but not be limited to:

(i) Name of facility;

(ii) Name of employee(s) involved;

(iii) Address of facility;

(iv) Date of spill or accident;

(v) Date of report;

(vi) Short detailed summary of events; and

(vii) Procedure(s) used to clean the spill or accident.

(11) All spills shall be recorded in a log that is maintained for a minimum of three (3) years from the date of the last entry in the log.

(g) Treatment, destruction, and destination facilities shall:

(1) Store regulated medical waste in a manner and location that maintains the integrity of the packaging;

(2) Maintain regulated medical wastes in a non-putrescent state, using refrigeration or freezing when necessary;

(3) Lock outside storage areas containing regulated medical wastes to prevent unauthorized access;

(4) Designate and label regulated medical waste storage areas not limited to authorized personnel by posting a sign stating "Warning: Regulated Medical Waste" and/or displaying the international biohazard symbol at all points of access; and

(5) Store regulated medical waste in a manner and location that is not accessible to animals and does not provide a breeding place or a food source for insects or rodents.

(h) Treatment, destruction and destination facilities shall adhere to the following storage regulations:

(1) No regulated medical waste shall be stored more than fourteen (14) days;

(2) No facility shall store more than seven (7) times its total maximum daily capacity for treatment and/or destruction of regulated medical waste.

(3) All facilities shall formulate a plan and submit a copy to the Director for approval. At a minimum the plan shall:

(i) Address compliance with the requirements set forth in Section 15.2 (d), (f), (g,) (h), of these regulations, and shall provide for the removal of regulated medical waste to an alternate facility in the event that the facility is not in compliance with Section 15.2 (h)(1) and/or (2) of these regulations;

(ii) Be maintained at the treatment facility; and

(iii) Designate an emergency coordinator and an alternate emergency coordinator.

(4) The facility shall implement the appropriate section(s) of its plan under the following conditions:

(i) Its maximum storage capacity for regulated medical waste (as determined by Section 15.2(h)(2) of these regulations) has been exceeded; or

(ii) The storage time for regulated medical waste has exceeded fourteen (14) days; or

(iii) The facility operator anticipates exceeding the maximum storage capacity and/or the fourteen-(14) day storage time limit for regulated medical waste.

(5) A generator that also treats or destroys regulated medical waste generated on premises owned or operated by the generator shall be subject to the requirements of Section 15.2(h) of these regulations when the untreated regulated medical waste is stored in a centralized storage area prior to treatment or destruction.

(i) Training/Notification Requirement: The owner of a treatment, destruction or destination facility shall notify in writing all employees involved with the treatment and destruction of regulated medical wastes of the provisions in Section 15.0 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

**Note: Only the section analyzed by the PHASYS team is included here as the entire regulation exceeded ~100 pages.