250-RICR-140-15-1. Medical Waste Regulations (version Periodic Refile, 12/31/2001 to 10/10/2010)

STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DEPARTMENT OF ENVIRONMENTAL MANAGEMENT RULES AND REGULATIONS GOVERNING THE GENERATION, TRANSPORTATION, STORAGE, TREATMENT, MANAGEMENT AND DISPOSAL OF REGULATED MEDICAL WASTE IN RHODE ISLAND [Regulation DEM-DAH-MW-01-92] Filing Date June 24, 1994 Effective Date July 14, 1994 -ii- CONTENTS 1.00 AUTHORITY:..................................................................................................................................1 2.00 PURPOSE, SCOPE, AND APPLICABILITY...............................................................................1 2.01 PURPOSE: ........................................................................................................................................1 2.02 SCOPE AND APPLICABILITY ....................................................................................................1 2.03 REGULATED MEDICAL WASTE:..................................................................................................2 2.04 REGULATED MEDICAL WASTE - EXCLUSIONS AND EXEMPTIONS:................................3 3.00 ENFORCEMENT AND INSPECTIONS ...........................................................................................4 4.00 EFFECTIVE DATES.......................................................................................................................5 5.00 DEFINITIONS .................................................................................................................................5 06.00 IDENTIFICATION AND SEGREGATION OF REGULATED MEDICAL WASTES .........10 6.01 APPLICABILITY ..............................................................................................................................10 6.02 IDENTIFICATION........................................................................................................................10 6.03 SEGREGATION:...............................................................................................................................11 7.00 PACKAGING AND CONTAINMENT OF REGULATED MEDICAL WASTES..................11 7.01 GENERAL PACKAGING AND CONTAINMENT REQUIREMENTS:....................................11 7.02 PACKAGING REQUIREMENTS FOR SHARPS......................................................................12 7.03 PACKAGING REQUIREMENTS FOR FLUIDS IN BULK QUANTITIES:............................13 7.04 PACKAGING AND CONTAINMENT REQUIREMENTS FOR OTHER REGULATED MEDICAL WASTES:.................................................................................................................................13 8.00 STORAGE OF REGULATED MEDICAL WASTES ..................................................................13 8.01 APPLICABILITY ..........................................................................................................................13 8.02 EXEMPTIONS.................................................................................................................................14 8.03 GENERAL STORAGE REQUIREMENTS ..................................................................................14 9.00 DECONTAMINATION STANDARDS FOR REUSABLE CONTAINERS ............................14 9.01 APPLICABILITY ..........................................................................................................................15 9.02 STANDARDS .................................................................................................................................15 10.00 ON-SITE TRANSPORT OF REGULATED MEDICAL WASTES:..........................................15 -iii- 11.00 LABELING AND MARKING REGULATED MEDICAL WASTE FOR OFF-SITE TRANSPORT ..............................................................................................................................................16 11.01 APPLICABILITY ..........................................................................................................................16 11.02 LABELING REQUIREMENTS:..................................................................................................16 11.03 MARKING (IDENTIFICATION) REQUIREMENTS: .............................................................17 12.00 ON-SITE TREATMENT AND/OR DESTRUCTION OF REGULATED MEDICAL WASTE 17 12.01 APPLICABILITY ..........................................................................................................................18 12.02 RECORDKEEPING REQUIREMENTS FOR ON-SITE INCINERATION...........................18 12.03 REPORTING REQUIREMENTS FOR ON-SITE INCINERATION ......................................19 12.04 ON-SITE STEAM STERILIZATION STANDARDS: ...............................................................20 12.05 RECORDKEEPING FOR ALTERNATE ON-SITE TREATMENT AND/OR DESTRUCTION METHODS:...................................................................................................................22 13.00 GENERATOR REQUIREMENTS FOR OFF-SITE TRANSPORTATION OF REGULATED MEDICAL WASTE ..........................................................................................................22 13.01 APPLICABILITY ..........................................................................................................................22 13.02 GENERAL REQUIREMENTS: ...................................................................................................23 13.03 USE OF THE TRACKING FORM ..............................................................................................28 13.04 GENERATORS EXPORTING REGULATED MEDICAL WASTE: ......................................29 13.05 RECORDKEEPING ......................................................................................................................29 13.06 EXCEPTION/DISCREPANCY REPORTING ...........................................................................31 13.07 SMALL QUANTITY GENERATOR REPORTING..................................................................32 13.08 ADDITIONAL REPORTING:......................................................................................................33 14.00 TRANSPORTER REQUIREMENTS FOR OFF-SITE TRANSPORTATION OF REGULATED MEDICAL WASTE ..........................................................................................................33 14.01 APPLICABILITY ..........................................................................................................................33 14.02 EPA TRANSPORTER NOTIFICATION:...................................................................................34 14.03 REGULATED MEDICAL WASTE TRANSPORTER PERMIT REQUIREMENTS............34 14.04 ACCEPTING REGULATED MEDICAL WASTE FOR TRANSPORT..................................38 14.05 USE OF THE MEDICAL WASTE TRACKING FORM...........................................................39 -iv- 14.06 MARKING (IDENTIFICATION)............................................................................................42 14.07 DELIVERY OF REGULATED MEDICAL WASTE.................................................................43 14.08 MANAGEMENT OF SPILLS.......................................................................................................43 14.09 OTHER INSPECTIONS AND DEPARTMENT ACTIONS:.....................................................45 14.10 PERSONNEL/EQUIPMENT........................................................................................................46 14.11 CONTAINERIZATION OF REGULATED MEDICAL WASTE: ...........................................46 14.12 TEMPORARY STORAGE: ..........................................................................................................46 14.13 RECORDKEEPING ......................................................................................................................47 14.14 REPORTING: ................................................................................................................................47 14.15 RAIL SHIPMENTS OF REGULATED MEDICAL WASTE....................................................49 14.16 ADDITIONAL REPORTING:......................................................................................................50 15.00 TREATMENT, DESTRUCTION AND DESTINATION FACILITIES...................................50 15.01 APPLICABILITY:..........................................................................................................................50 15.02 REQUIREMENTS FOR TREATMENT, DESTRUCTION, AND DESTINATION FACILITIES................................................................................................................................................51 15.03 USE OF THE TRACKING FORM ..............................................................................................54 15.04 TRACKING FORM DISCREPANCIES .....................................................................................57 15.05 RECORDKEEPING ......................................................................................................................57 15.06 ADDITIONAL REPORTING:.......................................................................................................58 15.07 TREATMENT, DESTRUCTION, AND DISPOSAL OF REGULATED MEDICAL WASTES 58 16.00 REGISTRATION FOR GENERATORS OF REGULATED MEDICAL WASTE.................60 16.01 GENERAL REQUIREMENTS ....................................................................................................60 16.02 REGISTRATION OF MORE THAN ONE GENERATOR AT THE SAME SITE ................62 16.03 ANNUAL REGISTRATION FEE ................................................................................................63 17.00 LICENSES FOR STORAGE, TREATMENT AND/OR DESTRUCTION OF REGULATED MEDICAL WASTE ....................................................................................................................................63 17.01 GENERAL REQUIREMENTS ....................................................................................................63 17.02 REGULATED MEDICAL WASTE STORAGE, TREATMENT AND/OR DESTRUCTION -v- LICENSE FEES ..........................................................................................................................................65 18.00 VARIANCES..................................................................................................................................65 18.01 APPLICATION:...............................................................................................................................65 18.02 REVIEW:..........................................................................................................................................65 -1- 1.00 AUTHORITY: These Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island are promulgated pursuant to the authority conferred under Chapter 23-19.12 of the General Laws of Rhode Island, as amended, and are established for the purpose of adopting standards for the handling, transportation, treatment and disposal of medical wastes by health care facilities, laboratories, and other medical waste generators. 2.00 PURPOSE, SCOPE, AND APPLICABILITY 2.01 PURPOSE: These rules and regulations serve the following purposes: (a) To protect the public health and the environment from the effects of improper management of medical waste through the assurance of proper, adequate and sound management of regulated medical waste; (b) To establish comprehensive standards and procedures governing the generation, transportation, storage, treatment, destruction and disposal of regulated medical waste. (c) To establish a program for tracking medical waste shipments pursuant to Chapter 23-19.12 of the General Laws of Rhode Island, as amended. (d) To establish a program for permitting, licensing, and/or registration of persons who generate, transport, store, treat, destroy, and/or dispose of regulated medical waste. (e) To establish a program for evaluating technologies for treating and/or destroying regulated medical waste. 2.02 SCOPE AND APPLICABILITY (a) These regulations shall apply to persons who generate, transport, store, treat, manage and/or dispose of regulated medical waste as defined in Section 5.00 of these regulations. (b) Generators, transporters, and owners or operators of intermediate handling facilities or destination facilities who transport, offer for transport, or otherwise manage regulated medical waste within Rhode Island shall comply with these regulations. (c) Regulated medical waste becomes subject to these regulations at the time and in the location that the material becomes waste, and shall remain subject to these regulations until such time as the regulated medical waste has been both treated and destroyed. (d) These regulations shall supplement and not replace all other environmental statutes both State and Federal. In cases of regulation under more than one -2- environmental statute the administrative authority shall determine the order and manner of compliance in the fashion that most fully effectuates the requirements and policies of the statutes involved. 2.03 Regulated Medical Waste: Means a special category of solid waste1 that includes specific types of medical waste subject to the handling and tracking requirements of these regulations. A regulated medical waste is any waste, as defined in these regulations, generated in the diagnosis (including testing and laboratory analysis), treatment, (e.g., provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the preparation of human remains for burial or cremation, or in the production or testing of biologicals, or in the development of pharmaceuticals, that is listed in this Section but is not excluded or exempted in Section 2.04 of these regulations. Regulated medical wastes mixed with nonhazardous solid wastes shall be considered regulated medical wastes. For the purposes of these regulations, the following categories of medical wastes are regulated medical waste: (a) Cultures and Stocks: Cultures and stocks of infectious agents and associated biologicals, including: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures. (b) Pathological Wastes: Human pathological wastes, including tissues, organs, and body parts that are removed during surgery or autopsy, or other medical procedures (e.g., obstetrical procedures). (c) Human Blood, Body Fluids and Blood Products (1) Liquid waste human blood or body fluids; (2) Products of blood; (3) Items saturated and/or dripping with human blood or body fluids; (4) Items that were saturated and/or dripping with human blood or body fluids that are caked with dried human blood or body fluids; including, but not limited to, serum, plasma, and other blood components, and their containers (e.g., blood bags and blood vials) and body fluids as defined in these regulations; or (5) Specimens of body fluids and their containers. 1The term "solid waste" includes solid, semisolid, or liquid materials, but does not include domestic sewage materials identified in these regulations. -3- (d) Sharps: Sharps that have been used in animal or human patient care or treatment, including sharps generated from the preparation of human and animal remains for burial or cremation, or in medical, research, or industrial laboratories, including, but not limited to, hypodermic needles, syringes with or without the attached needle, pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, glass carpules, and glass culture dishes regardless of presence of infectious agents. Also included are other types of broken or unbroken glassware that have been used in animal or human patient care or treatment, such as used slides and cover slips. For the purpose of these regulations, disposable syringes and needles are considered regulated medical waste after one use. (e) Animal Waste: Contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research, including research in veterinary hospitals, production of biologicals, or testing of pharmaceuticals. (f) Isolation Wastes: Biological waste and discarded materials contaminated with blood, excretion, exudates, or secretions from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases. A list of these diseases may be found in Appendix IV. (g) Unused Sharps: Unused, discarded sharps, as defined in Section 2.03(d) of these regulations. (h) Spill/Cleanup Material: Any material collected during or resulting from the cleanup of a spill of regulated medical waste. (i) Mixtures: Any waste which is a mixture of regulated medical waste and some other type of waste which is neither radioactive nor a hazardous waste of a type other than regulated medical waste . 2.04 REGULATED MEDICAL WASTE - EXCLUSIONS AND EXEMPTIONS: The following categories of medical waste are specifically excluded from the definition of regulated medical waste: (a) Hazardous Waste: Materials identified or listed under DEM Rules and Regulations for Hazardous Waste Management. Regulated medical waste that is mixed with hazardous waste shall be defined as hazardous waste and shall be regulated in accordance with DEM Rules and Regulations for Hazardous Waste Management. (b) Household Medical Waste -4- (1) Medical waste generated by individuals on the premises of a single-family home or single-family dwelling unit or by members of households residing in single and multiple residences, hotels, and motels which serve as a residence for individuals, provided the dwelling is not serving as a commercial or professional office where individuals who are not members of the family residing at such dwelling are receiving medical care by a health care professional; (2) The exemption in 2.04(a)(1) also includes the wastes generated by health care providers in private homes where they provide medical services to individuals residing in said homes; and (3) Medical waste generated and disposed of with residential solid wastes from a single family residential premise or single-family dwelling unit shall be exempt from these regulations except where such medical waste is generated from commercial or professional offices. (c) Incinerator Ash and Treatment/Destruction Residue: Regulated medical waste that has been both treated and destroyed is no longer regulated medical waste; this includes ash from incineration of regulated medical waste provided the ash meets the definition for treated regulated medical waste and destroyed regulated medical waste, and residues from wastes that have been both treated and destroyed (e.g., waste that has been subjected to decontamination and grinding, or chemical disinfection followed by grinding, or steam sterilization followed by shredding). Notwithstanding this exemption, incinerator ash and treatment/ destruction residue may be a hazardous waste and shall be handled in accordance with the provisions of Section 2.04(a) of these regulations. (d) Human Remains: Human remains (e.g., corpses and anatomical parts) that are stored, transported, or otherwise managed for purposes of interment or cremation. However, regulated medical waste attached to, or within, a corpse is not exempt from these regulations and shall be removed and then managed as regulated medical waste according to these regulations. (e) Etiologic Agents: Etiologic agents that are being transported intrastate and/or interstate between facilities pursuant to regulations set by the U.S. Department of Transportation, the U.S. Department of Health and Human Services, and all other applicable shipping requirements. (f) Enforcement Samples: Enforcement samples, including samples of regulated medical waste obtained during enforcement procedures by authorized U.S. Environmental Protection Agency personnel and the State of Rhode Island. 3.00 Enforcement and Inspections -5- (a) Failure to comply with any of the provisions of these regulations or of the terms and conditions of any permit, license or registration granted or order issued hereunder constitutes a violation of the Rhode Island Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste Act. (b) Upon a determination by the Director that a violation of Chapter 23-19.12 of the General Laws of Rhode Island, as amended, or the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste has occurred or is about to occur, the Director shall initiate one or more of the actions set forth in Rhode Island General Laws 42-17.1-2(u). (c) A violation of Chapter 23-19.12 of the General Laws of Rhode Island, as amended, or the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste may give rise to civil or administrative penalties as set forth in Section 23-19.12-15 of the General Laws of Rhode Island, as amended. (d) Pursuant to Section 23-19.12-7 of the General Laws of Rhode Island, as amended, the Director is authorized to conduct such inspections of facilities, as he or she deems necessary or desirable, where regulated medical waste is generated, stored, treated, destroyed, transferred, or otherwise managed. The Director is also authorized to conduct inspections of any vehicles used to transport regulated medical waste and any records required pursuant to the authority granted under Chapter 23-19.12 of the General Laws of Rhode Island, as amended. Inspections shall be conducted during the facility's normal business hours unless the Director determines that an immediate inspection is necessary. 4.00 EFFECTIVE DATES (a) These Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island, shall be effective twenty (20) days after they are filed with the Secretary of State. (b) The length of time parties shall keep records required under this part is automatically extended in the case where Rhode Island initiates an enforcement action, for which those records are relevant. For the purpose of these regulations, relevant records are those records which reference or refer to the matter which is the subject of the enforcement action. In such cases, the parties shall keep relevant records until the conclusion of the enforcement action. 5.00 DEFINITIONS Wherever used in these regulations the following terms shall have the following meanings: -6- "Biologicals" means preparations made from living organisms and their products, including vaccines, cultures, etc., intended for use in diagnosing, immunizing or treating humans or animals or in research pertaining thereto. "Blood products" means any product derived from human blood, including but not limited to blood plasma, platelets, red or white blood corpuscles, and other derived licensed products, such as interferon, etc. "Body fluids" means liquid emanating or derived from humans and limited to blood; cerebrospinal, synovial, pleural, peritoneal and pericardial fluids; dialysate and amniotic fluids; and semen and vaginal secretions but excluding feces, urine, nasal secretions, sputum, sweat, tears, vomitus, saliva, and breast milk, unless any such excluded substance contains visible blood or is isolation waste. "Building" means any structure used or intended for supporting or sheltering any use or occupancy subject to these regulations. "Central collection point" means a location where a generator consolidates regulated medical waste brought together from original generation points prior to its transport off-site to a transfer facility, an intermediate handler, or a destination facility. A storage facility shared by Small Quantity Generators within a building is considered a Central Collection Point. "Decontamination" means the process of substantially reducing or eliminating the presence of harmful substances, such as infectious agents, so as to substantially reduce the likelihood of disease transmission from those substances. "DEM" means the Rhode Island Department of Environmental Management. "Department" means the Rhode Island Department of Environmental Management. "Destination facility" means the disposal facility, the incineration facility, or any other type of facility that both treats and destroys regulated medical waste, to which a consignment of such is intended to be shipped. A destination facility is subject to the Rhode Island Rules and Regulations for Solid Waste Management Facilities if the facility is located within the State of Rhode Island. "Destroyed regulated medical waste" means regulated medical waste that has been ruined, torn apart, or mutilated through processes such as thermal treatment, melting, shredding, grinding, tearing or breaking, so that it is no longer generally recognizable as medical waste. Encapsulation or compaction of regulated medical waste does not render such waste destroyed regulated medical waste. "Destruction facility" means a facility that destroys regulated medical waste by ruining or mutilating it, or tearing it apart and may include a transfer station, a solid waste management facility, or any other facility that destroys regulated medical waste. A destruction facility is subject to the Rhode Island Rules and Regulations for Solid Waste Management Facilities if the facility is located within the State of Rhode Island. -7- "Director" means the Director of the Rhode Island Department of Environmental Management or his or her designee. Said designee may be an employee of the Department of Environmental Management or from the Department of Health. "Disposal" means the discharge, deposit, injection, dumping, spilling, leaking, abandoning, or placing of any regulated medical waste in, on, into, or onto any land, other surface, or building or vehicle, or trailer, or other containment structure, or into any water, watercourse, stormwater system or sewer system. "Domestic Sewage" means any human excremental liquid or substance, any putrescible vegetable matter, garbage and filth, including, but not limited to, the discharge of toilets, laundry tubs, washing machines, sinks, and dishwashers, which is disposed of by means of a septic system or sanitary sewer. "Encapsulation" means the application of a substance which either creates a membrane over the surface and/or penetrates the material and binds its components together. "EPA" means the United States Environmental Protection Agency. "Facility" means all land and structures, other appurtenances, and improvements on the land, used for generating, handling, storing, treating, destroying, or disposing of regulated medical waste; provided that all land and structures are under the control of a single person or legal entity. A facility may consist of several generating, handling, storage, treatment, destruction, or disposal operation units. "FIFRA" means the Federal Insecticide, Fungicide and Rodenticide Act. "Generator" means any person whose act or process produces regulated medical waste as defined in these regulations, or whose act first causes a medical waste to become subject to regulation. In the case where more than one person (e.g., doctors with separate medical practices) is located in the same building, each individual business entity shall be considered a separate generator for purposes of these regulations. The universe of medical waste generators includes, but is not limited to, hospitals, physicians' offices, dental offices, veterinary practices, funeral homes, laboratories that perform health-related analyses or services, nursing homes, and hospices. "Hazardous Waste" means any waste or combination of wastes of a solid, liquid, contained gaseous, or semi-solid which, because of its quantity, concentration, or chemical or physical characteristics, may cause or significantly contribute to an increase in mortality or an increase in serious irreversible or incapacitating reversible illness; or pose a substantial present or potential hazard to human health or to the environment. "Incineration" means the treatment and destruction of regulated medical waste using controlled flame combustion in an arrangement of chambers and equipment designed for burning solid, semi-solid or gaseous combustible waste to a gas and residue. -8- "Infectious agent" means any organism, such as a virus or a bacteria, that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans. "Intermediate handler" is a facility that either treats regulated medical waste or destroys regulated medical waste but does not do both. The term, as used in these regulations, does not include transporters. An intermediate handler shall obtain a license for a Solid Waste Management Facility from DEM, Office of Waste Management, as per the Rhode Island Rules and Regulations for Solid Waste Management Facilities. "Laboratory" means any research, analytical, or clinical facility that performs health care related analysis or service. This includes, but is not limited to, medical, pathological, pharmaceutical, and other research, commercial, or industrial laboratories. "Landfill" means a disposal facility or part of a facility where regulated medical waste is placed in or on the land and which is not a land treatment facility, a surface impoundment, or an injection well. "Medical Waste Tracking Form" means the form used for identifying the quantity, composition, and the origin, routing, and destination of regulated medical waste during its transportation from the facility of generation to the point of transfer, disposal, treatment, destruction, or storage. "Private Courier Service" means an entity whose primary business is the interstate and/or intrastate transport of packages, parcels and similar items for commercial purposes, and which transports regulated medical waste as less than ten percent (10%) of their total activity in Rhode Island, both in terms of volume and revenue. "Off-site" means a facility or area for the storage, treatment, and/or disposal of regulated medical waste which is not on the generator's site (i.e., "on-site") or a facility or area which receives regulated medical waste for storage or treatment which has not been generated "on-site" at that facility. "On-site" means land area and appurtenances thereon and thereto used for the collection, storage, processing, treatment, and/or disposal of regulated medical waste on the same or geographically contiguous property at which regulated medical waste is generated. Two or more pieces of property either owned or operated by a single person or legal entity are considered a single site. "Original generation point" means the location where regulated medical waste is generated. Waste may be taken from original generation points to a central collection point prior to off-site transport or on-site treatment. "Person" means an individual, trust, firm, joint stock company, corporation (including a government corporation), partnership, association, State, municipality, commission, political subdivision of a State, any interstate body, or any department, agency or instrumentality of the United States. "Regulated medical waste" is defined in Section 2.03 of these regulations. -9- "Sanitary sewer" means the collection system which transports domestic sewage and waste waters to a municipal wastewater treatment facility. Said treatment facility shall include primary and secondary wastewater treatment. "Small Quantity Generator" means a generator of regulated medical waste who generates, transports, or offers for transport less than fifty (50) pounds of regulated medical waste in a calendar month. "Solid waste" means garbage, refuse, and other discarded solid materials generated by residential, institutional, commercial, industrial and agricultural sources but does not include solids or dissolved solids in domestic sewage sludge, nor does it include hazardous waste. For the purpose of these regulations, solid waste shall also include non-hazardous liquid, semi-solid, and containerized gaseous waste . "Spill" means any planned or unplanned release, leaking, pumping, pouring, emitting, or depositing of regulated medical waste in violation of the requirements of these regulations. "Steam Sterilization" means a treatment method for regulated medical waste utilizing saturated steam within a pressure vessel (known as steam sterilizer, autoclave, or retort) at time lengths and temperatures sufficient to kill infectious agents within the waste. "Storage" means the temporary holding of regulated medical wastes at a designated accumulation area before treatment, destruction, disposal, or transport to another location. "These regulations" means all parts of the Rules and Regulations Governing Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island. "Tracking form" [See Medical Waste Tracking Form]. "Transfer facility" means any transportation-related facility including loading docks, parking areas, storage areas and other similar areas where shipments of regulated medical waste are held during the course of transportation. A transfer facility shall obtain a license for a Solid Waste Management Facility from DEM, Office of Waste Management, as per the Rhode Island Rules and Regulations for Solid Waste Management Facilities. "Transportation" means the movement of regulated medical waste from the facility of generation to any intermediate points, and finally to the point of ultimate storage or disposal. "Transporter" means a person engaged in the off-site transportation of regulated medical waste unless said person is otherwise exempted by these regulations. -10- "Treated regulated medical waste" means regulated medical waste that has been treated to substantially reduce or eliminate its potential for causing disease, but which has not yet been destroyed. "Treatment" when used in the context of regulated medical waste management means any method, technique, or process designed to: (1) Completely and reliably inactivate vegetative bacteria, fungi, viruses, parasites, and mycobacteria at a 6 Log10 reduction or greater; and (2) Completely and reliably inactivate Bacillus stearothermophilus spores or Bacillus subtilis spores at a 4 Log10 reduction or greater. "Treatment facility" when used in the context of medical waste refers to any facility that accepts regulated medical waste and changes its biological character or composition so as to substantially reduce or eliminate its potential for causing disease, but does not destroy the medical waste. A treatment facility may include a transfer station, a solid waste management facility, or any other facility that treats regulated medical waste. A treatment facility is also subject to the Rhode Island Rules and Regulations for Solid Waste Management Facilities if the facility is located within the State of Rhode Island. "Universal biohazard symbol" means the symbol shown in Appendix VII of these regulations. "Untreated regulated medical waste" means regulated medical waste that has not been treated to substantially reduce or eliminate its potential for causing disease. 06.00 Identification and Segregation Of Regulated Medical Wastes 6.01 APPLICABILITY (a) Generators shall comply with the requirements of this section from the time and location that an item becomes regulated medical waste. (b) Generators shall comply with Section 8.00 of these regulations for on-site storage. (c) Training/Notification Requirement: Generators shall notify in writing all employees involved with the identification and segregation of regulated medical wastes of the provisions in Section 6.00 of these regulations. This training/ notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 6.02 IDENTIFICATION (a) A person who generates a medical waste within the State of Rhode Island shall determine if that waste is a regulated medical waste. Any wastes that contain regulated medical waste mixed with general solid waste shall be managed as regulated medical wastes. -11- (b) Any regulated medical wastes which meet the definition of "hazardous waste", or which are mixed with hazardous wastes shall be managed as hazardous waste in accordance with the most current DEM Rules and Regulations for Hazardous Waste Management. 6.03 SEGREGATION: Generators shall segregate regulated medical waste from the general waste stream to the maximum extent practicable to ensure the special handling and treatment required by these regulations. Separation from the general waste stream shall occur at the point at which the regulated medical waste is generated. (a) Generators shall segregate regulated medical wastes into the following groups: (1) Sharps and unused sharps, including sharps containing residual fluid; (2) Fluids in bulk quantities (quantities greater than twenty cubic centimeters (20 cm3)); and (3) Other regulated medical wastes. (b) Regulated medical wastes shall be placed in suitable containers, according to the requirements of Section 7.00 of these regulations, at the source of origin (e.g., patient room, operating room, etc.). (c) If other solid waste is placed in the same container(s) as regulated medical waste, then the entire contents of the container(s) shall be managed as regulated medical waste and shall meet all the requirements of these regulations. (d) If a generator manages all solid waste as regulated medical waste, the identification and segregation requirements of Section 6.00 of these regulations need not be met. However, the entire solid waste stream of this generator shall then be managed as regulated medical waste and shall meet all remaining handling and management requirements of these regulations. 7.00 PACKAGING AND CONTAINMENT OF REGULATED MEDICAL WASTES 7.01 GENERAL PACKAGING AND CONTAINMENT REQUIREMENTS: Regulated medical waste shall be properly packaged to assure effective containment throughout the handling, storage, transport, and treatment process. In addition to the specific packaging and containment requirements for each category of regulated medical waste contained in Sections 7.02, 7.03 and 7.04 of these regulations, the following general requirements shall be met before transporting or offering for transport such waste off-site or within the generating facility: (a) Generators shall ensure that all regulated medical waste is placed in a container or containers that are: -12- (1) Rigid; (2) Leak-resistant; (3) Impervious to moisture; (4) Of a strength sufficient to prevent tearing or bursting under normal conditions of use and handling; and (5) Sealed to prevent leakage during transport. (b) Materials for packaging shall be strong enough to remain intact during whatever type of handling, storage, and transport the container(s) may undergo. (c) Mechanical compaction of regulated medical waste shall not be conducted prior to treatment and/or disposal, unless the mechanical compaction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste. (d) Training/Notification Requirement: Generators shall notify in writing all employees involved with packaging and containment of regulated medical wastes of the provisions in Section 7.00 of these regulations. This training/ notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 7.02 PACKAGING REQUIREMENTS FOR SHARPS (a) In addition to the general packaging and containment requirements for regulated medical wastes in Section 7.01 of these regulations, all sharps and unused sharps, including sharps with residual fluids, shall be packaged in containers that are puncture-resistant. Any sharps placed into such a container shall not be manipulated inside the container and/or shall not be removed from said container under any circumstances. The sharps shall be placed directly into the container without recapping, clipping, bending, or breaking unless one of the following criteria are met: (1) The employer can demonstrate that the requirements of this section are not feasible for a specific medical procedure; or (2) Such recapping or needle removal is accomplished through the use of a mechanical device or one-handed technique specifically approved in writing by the Director. (b) Sharps containers shall be assembled and utilized as intended by the manufacturer at all times while in use. Sharps containers with openings large enough to allow entry of any human hand shall also be subject to any additional physical and/or administrative controls necessary to prevent access by the public during normal conditions of use. -13- (c) The container shall be sealable in a manner that prevents spillage of contents during transport. The container shall identify the contents as regulated medical waste by displaying the Universal Biohazard Symbol (Appendix VII) on the outside of the container. 7.03 PACKAGING REQUIREMENTS FOR FLUIDS IN BULK QUANTITIES: In addition to the general packaging and containment requirements for regulated medical wastes in Section 7.01 of these regulations, human blood and blood products and body fluids in quantities greater than twenty cubic centimeters (20 cm3) shall be packaged in containers that are break-resistant and tightly lidded or stoppered. The container shall identify the contents as regulated medical waste by displaying the Universal Biohazard Symbol (Appendix VII) on the outside of the container. 7.04 PACKAGING AND CONTAINMENT REQUIREMENTS FOR OTHER REGULATED MEDICAL WASTES: In addition to the general packaging and containment requirements for regulated medical wastes in Section 7.01 of these regulations, those regulated medical wastes which are not sharps or unused sharps or fluids in bulk quantities, (including, but not limited to, cultures and stocks, non-liquid pathological wastes, non-liquid animal wastes, non-liquid isolation wastes, materials saturated with blood) shall be packaged in either rigid containers that are designed to be tightly sealable or in plastic bags that meet the following requirements: (a) The plastic bags shall be impervious to moisture and be tear-resistant; (b) The plastic bags shall be a distinctive red or orange color, or clear (i.e., without color). If a clear bag is used then the universal biohazard symbol (Appendix VII) shall be appropriately displayed on the bag; (c) In order to allow the use of "single plastic bags", the bags shall be constructed of material of sufficient single thickness strength to pass the 165-gram dropped dart impact resistance test as prescribed by the American Society for Testing and Materials (ASTM) Dart Test (ASTM Standard #D-1709-91) and certified by the manufacturer. Otherwise, "double bagging" (i.e., the use of two plastic bags, one inside the other) is required. (d) A container (e.g., a step-can) used on-site to hold regulated medical waste shall have either a red or orange plastic bag plainly visible; or if a clear bag is used then the universal biohazard symbol (Appendix VII) shall be displayed on the container as well as on the bag. 8.00 STORAGE OF REGULATED MEDICAL WASTES 8.01 APPLICABILITY (a) Any person who stores regulated medical waste prior to treatment or disposal on-site or transport off-site shall comply with the storage requirements of this section. -14- (b) Training/Notification Requirement: Generators shall notify in writing all employees involved with the storage of regulated medical wastes of the provisions in Section 8.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 8.02 EXEMPTIONS Sharps containers, currently in use, are exempt from the generator storage requirements provided they meet all the requirements in Sections 7.01 and 7.02 of these regulations; 8.03 GENERAL STORAGE REQUIREMENTS (a) The regulated medical waste shall be stored in a manner and location which maintains the integrity of the packaging and provides protection from flooding and from adverse weather conditions such as rain, snow, ice, sleet, hail, and wind. All areas used for the storage of regulated medical waste shall be constructed of finished materials that are impermeable to moisture and capable of being easily maintained in a sanitary condition. (b) On-site storage areas shall be restricted to authorized personnel. Outdoor storage areas, such as dumpsters, sheds, tractor trailers, or other storage areas, that contain regulated medical waste shall be securely locked in order to prevent unauthorized access. (c) The regulated medical waste shall be stored in a manner that prevents access by, and does not provide a breeding place or a food source for, insects, rodents, or other animals. (d) The storage area shall be clearly identified as containing regulated medical waste through the posting of universal biohazard signs or signs containing the following wording: MEDICAL WASTE or REGULATED MEDICAL WASTE. (e) The regulated medical waste shall be maintained in a nonputrescent state. Total storage of regulated medical waste shall not exceed fifty (50) pounds or the average quantity of regulated medical waste generated over five (5) consecutive calendar days, whichever condition shall allow storage for the longer period of time. (f) Regulated medical waste shall not be compacted, undergo grinding, or be subject to violent mechanical stress on-site unless the regulated medical waste has been treated prior to compaction, grinding, or other mechanical stress; or, unless the compaction, grinding, or mechanical stress and the treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste. 9.00 DECONTAMINATION STANDARDS FOR REUSABLE CONTAINERS -15- 9.01 APPLICABILITY (a) Generators, transporters, intermediate handlers, and destination facility owners and operators shall comply with the requirements of this section with respect to reusing containers. (b) Training/Notification Requirement: Generators shall notify in writing all employees involved with the decontamination of reusable containers for regulated medical wastes of the provisions in Section 9.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 9.02 STANDARDS (a) All non-rigid packaging and inner liners used for the packaging of medical waste shall be managed as regulated medical waste and shall not be reused. (b) Any container used for the storage and/or transport of regulated medical waste and designated for reuse once emptied, shall be decontaminated after each use. Decontamination can be accomplished by chemical disinfection, steam sterilization, thermal inactivation, or other suitable process that is appropriate both for the type of container to be decontaminated and for the type of contamination present. (c) If any container used for the storage and/or transport of regulated medical waste is for any reason not capable of being rendered free of contamination in accordance with the requirements of Section 9.02(b) of these regulations, the container shall be managed (i.e., labeled and treated and/or disposed of) as regulated medical waste. 10.00 On-Site Transport of Regulated Medical Wastes: To ensure the safe transport of regulated medical wastes within the generating facility (on-site), generators shall comply with the following requirements: (a) The regulated medical waste shall be properly packaged to ensure containment of the waste as described in Section 7.00 of these regulations; all containers and packages containing regulated medical wastes shall be sealed to prevent leakage or spillage while in transport. (b) The handling, transfer, and loading of packages and containers of regulated medical wastes shall be performed in a manner that does not destroy the integrity of the packaging. (c) Regulated medical waste shall not be subjected to violent mechanical stress during on-site transport. (d) (1) Wheeled carts shall be used for the transport of packages or containers of regulated medical wastes if these packages or containers will be -16- moved more than a short distance or if these packages or containers cannot be easily handled by one person (due to weight, size, shape, bulkiness, etc.) regardless of the distance to be moved. (2) Any regulated medical waste which is contained in plastic bags shall not be moved or transported in mechanical devices, dumb waiters, or chutes, unless the chutes are designed to prevent accumulation of wastes in corners and edges and are lined with materials which can be easily cleaned (e.g., stainless steel). (3) Carts used for the transport of packages and containers of regulated medical wastes shall be sturdy and shall be routinely cleaned and disinfected, and immediately cleaned and disinfected after use if the cart has been contaminated by medical waste. (4) Items other than regulated medical waste shall not be placed in the same cart with regulated medical waste at any point during on-site transportation. (e) The compaction of packages and containers of regulated medical wastes prior to or during on-site transport is prohibited. (f) Training/Notification Requirement: Generators shall notify in writing all employees involved with the on-site transport of regulated medical wastes of the provisions in Section 10.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 11.00 LABELING AND MARKING REGULATED MEDICAL WASTE FOR OFF-SITE TRANSPORT 11.01 APPLICABILITY (a) All containers used for the packaging and containment of regulated medical wastes shall be labeled with the universal biological hazard symbol (Appendix VII) or shall be clearly labeled as containing regulated medical waste. In addition all packages or containers which will be transported or offered for transport off-site shall meet the labeling and marking requirements of Section 11.00 of these regulations. (b) Training/Notification Requirement: Generators shall notify in writing all employees involved with the labeling and marking of regulated medical waste for off-site transport of the provisions in Section 11.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 11.02 LABELING REQUIREMENTS: Generators shall label each package or container of regulated medical waste with a water-resistant label affixed to or printed on the outside of the container. The label shall -17- include the words "Medical Waste", or display the universal biohazard symbol (Appendix VII). Red plastic bags used as inner packaging need not display a label. 11.03 MARKING (IDENTIFICATION) REQUIREMENTS: Generators and intermediate handlers shall mark each package or container of regulated medical waste according to the following marking requirements before the waste is transported or offered for transport off-site. (a) The outermost surface of each package or container prepared for shipment shall be marked with indelible lettering on a water-resistant identification tag of sufficient dimension and contain the following information: (1) Generator's or intermediate handler's name; (2) Generator's or intermediate handler's address; (3) Transporter's name (if applicable); (4) Transporter's Rhode Island Regulated Medical Waste Transporter Permit number (if applicable); (5) Date of shipment (date of off-site transport); and (6) Identification of contents as medical waste. (b) When regulated medical waste is transported by more than one transporter, each transporter other than the transporter who accepted the waste from the generator shall affix a water-resistant identification tag on the outside of the secondary container. Such tag shall be at least three inches by five inches and shall be affixed in such manner as not to obscure previously affixed identification tags. Such tag shall indicate in indelible writing the name, address, business location, and Rhode Island Regulated Medical Waste Transporter Permit number of the transporter affixing the tag and the date such transporter accepted the waste. (c) In addition, if the generator has used inner containers, including sharps and fluid containers, each inner container shall be marked with indelible ink or imprinted with water-resistant tags. The marking shall contain the following information: (1) Generator's or intermediate handler's name; (2) Generator's or intermediate handler's address; and (3) Identification of type of contents of container as medical waste. 12.00 ON-SITE TREATMENT AND/OR DESTRUCTION OF REGULATED MEDICAL WASTE -18- 12.01 APPLICABILITY (a) The regulations in this section apply to generators of regulated medical waste that conduct on-site treatment and/or destruction of regulated medical waste, and to generators that accept regulated medical waste for treatment and/or destruction. (b) Generators that accept regulated medical waste from other generators for treatment and/or destruction shall apply for a license, in accordance with the requirements contained in Section 17.00 of these regulations, from: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 (c) Generators are also subject to the requirements of all applicable State solid waste and air emission regulations. (d) Training/Notification Requirement: Generators shall notify in writing all employees involved with on-site treatment and/or destruction of regulated medical wastes of the provisions in Section 12.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 12.02 RECORDKEEPING REQUIREMENTS FOR ON-SITE INCINERATION (a) Generators shall keep an operating log at their incineration facility that includes the following information: (1) The date each incineration cycle began; (2) The length of the incineration cycle; (3) The total quantity of waste incinerated per incineration cycle; (4) An estimate of the quantity of regulated medical waste incinerated per incineration cycle; (5) Generators shall compile the operating log required by Section 12.02(a) of these regulations from the effective date of these regulations; (6) Generators shall retain the operating log for at least three (3) years from the date of the last entry in the log. (b) Generators with on-site incinerators that accept regulated medical waste from generator(s) subject to Section 13.02(b) of these regulations shall maintain the following information for each shipment of regulated medical waste accepted: (1) The date the waste was accepted; -19- (2) The name and address of the generator who originated the shipment; (3) The total weight of the regulated medical waste accepted from the originating generator; (4) The signature of the individual accepting the waste. (c) Generators with on-site incinerators that accept regulated medical waste from generators subject to the tracking form requirements shall keep copies of all tracking forms for a period of three (3) years from the date they accepted the waste. 12.03 REPORTING REQUIREMENTS FOR ON-SITE INCINERATION (a) General: The owner or operator of an on-site incinerator shall prepare and submit copies of the on-site incinerator report on the form provided in Appendix II of these regulations to: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 The reports shall summarize information collected in the operating log and shall contain the following information in the format provided in Appendix II of these regulations: (1) Facility name, mailing address, and location; (2) Facility type (e.g., hospital, laboratory); (3) Contact person; (4) Waste feed information; (5) The total number of incinerators at the facility that incinerate regulated medical waste and information concerning each incinerator. (b) Each report shall contain the following certification, signed by the facility owner or by owner's designee: "I certify that I have personally examined and am familiar with the information submitted in this and all attached documents, and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete." (c) Generators shall retain a copy of the on-site incinerator report form required under Section 12.03 of these regulations for three (3) years from the date of submission. Reports shall cover the period of January 1 to June 30 of each -20- year and from July 1 to December 31 of each year.2 These reports are due forty-five (45) days after the end of the reporting period. 12.04 ON-SITE STEAM STERILIZATION STANDARDS: A steam sterilizer used to convert untreated regulated medical waste into treated regulated medical waste shall be operated in accordance with the following requirements. In addition, operators of steam sterilizers shall be familiar with autoclaving techniques and hazards (i.e., burn protection and aerosol minimization). (a) The sterilizers shall be dedicated for waste only. The sterilizers shall be operated in accordance with the manufacturer's specifications for waste in regard to time, temperature, pressure, and capacity, provided that these specifications change the biological character or composition of the regulated medical waste so as to substantially reduce or eliminate its potential for causing disease. (b) If no manufacturer's specifications for waste exist, or if another combination of time, temperature, pressure and capacity is used, such combination shall be proven, on the basis of thorough tests, to render the regulated medical waste treated. These tests shall include a test to determine the capacity of this combination to completely and reliably inactivate Bacillus stearothermophilus spores at a 4 Log10 reduction or greater. (c) Regulated medical waste shall be steam sterilized in its primary container. The primary container shall be placed in the sterilization chamber so that sufficient space is provided between the chamber walls and the container to allow the steam to surround the container. The primary container shall be sealed loosely enough to allow the steam to penetrate the contents of the container, unless a self-venting bag is used. Caps and stoppers on bottles shall be loosened as well to facilitate steam penetration. (d) Unless a steam sterilizer is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, the operator of such sterilizer shall affix to the primary container temperature-sensitive tape which will indicate when the desired temperature is reached. (1) Regulated medical waste shall not be considered treated regulated medical waste unless: (i) The temperature-sensitive tape indicates that a temperature of at least 250 oF (121 oC) was reached during the sterilization process; or 2An initial report was required to be submitted for the period from the effective date of the regulations (14 April 1992) through 30 June 1992. -21- (ii) A temperature determined in accordance with Section 12.04(b) of these regulations was reached during the sterilization process; or (iii) A temperature recommended by the manufacturer of the sterilizer that is sufficient enough to render the infectious agents within the waste treated, was reached during the sterilization process; and (iv) In addition to attaining the specific temperature determined in accordance with Section 12.04(d)(1)(i), (ii) and/or (iii) above, said temperature shall be maintained for a period of time sufficient to completely and reliably inactivate Bacillus stearothermophilus spores at a 4 Log10 reduction or greater. (2) A record of this temperature shall be kept as explained in Section 12.04(g) of these regulations. (3) A steam sterilizer which is purchased after the effective date of this section, and used for waste sterilization, shall automatically and continuously monitor and record temperatures throughout the entire length of each steam sterilization cycle. This record shall be kept for three (3) years from the date the waste was treated. (e) At least once during every forty (40) hours of operation, tests shall be conducted to evaluate the effectiveness of the sterilization process, including tests of the capacity of such process to completely and reliably inactivate Bacillus stearothermophilus spores at a 4 Log10 reduction or greater. Each test shall include at least three (3) samples of test organisms placed in the medical waste load. One sample shall be placed approximately one-third of the way from the top of the load, one sample in the center of the load, and one sample approximately one-third of the way from the bottom of the load. A log shall be maintained recording the dates and results of such tests, and shall be kept for at least three (3) years from the date the of the last entry in the log. (f) At least once during every forty (40) hours of operation, a sterilization unit shall be evaluated to determine whether it is operating properly with respect to temperature and pressure. A log shall be maintained recording the dates and results of such evaluations and the dates of calibration. The log shall be kept for at least three (3) years from the date of the last entry in the log. (g) For each sterilization unit, a log shall be maintained which contains, as a minimum, the following information for each use: (1) Date; (2) Time; (3) Operator; (4) Type and approximate amount of regulated medical waste treated; -22- (5) Sterilization pressure reading; (6) Maximum temperature obtained during the sterilization process; and (7) The length of time that the sterilization pressure and temperature determined in accordance with Section 12.04(a) or (b) of these regulations were maintained. (h) The log required by Section 12.04(g) of these regulations shall be kept at least three (3) years from the date the waste was treated. 12.05 RECORDKEEPING FOR ALTERNATE ON-SITE TREATMENT AND/OR DESTRUCTION METHODS: Any method or process other than incineration or steam sterilization used by a generator for treatment and/or destruction of regulated medical waste on-site shall be approved by the Director in accordance with Section 15.07(e) of these regulations. Each generator shall maintain the following records: (a) The approximate quantity by weight, of regulated medical waste that is subject to the treatment and/or destruction process(es); (b) Approximate percent, by weight, of total waste treated and/or destroyed that is regulated medical waste; (c) For regulated medical waste accepted from generators meeting the exemption conditions in Sections 13.02(b) and 13.02(d) of these regulations, information identifying the generator, the date the waste was accepted, the weight of waste accepted, and the date the waste was treated and/or destroyed; (d) Results of all required quality assurance monitoring/procedures conducted to demonstrate compliance with the conditions of the approval granted by the Director in accordance with Section 15.07(e) of these regulations; and (e) Records shall be maintained by the generator for a period of at least three (3) years from the date the waste was treated and/or destroyed. 13.00 GENERATOR REQUIREMENTS FOR OFF-SITE TRANSPORTATION OF REGULATED MEDICAL WASTE 13.01 APPLICABILITY (a) A person who generates regulated medical waste and whose generating facility is located in Rhode Island, shall determine if that waste is a regulated medical waste (as defined in Sections 2.03 and 5.00 of these regulations). (b) Any generator that transports off-site or offers for transport off-site any regulated medical wastes shall comply with all requirements for such -23- transport set forth in Sections 6.00, 7.00, 8.00, 9.00, and 11.00 of these regulations. (c) A generator of regulated medical wastes shall determine the quantity of regulated medical wastes generated in a calendar month, and the quantity transported or offered for transport off-site for treatment, destruction, or disposal. (d) Vessels at port in Rhode Island are subject to the requirements of this section for those regulated medical wastes that are transported ashore in Rhode Island. The owner or operator of the vessel and the person(s) removing or accepting waste from the vessel are considered co-generators of the waste. (e) A generator that treats and destroys or disposes of regulated medical waste on-site (e.g., incineration, burial or sewer disposal covered by Section 307(b)-(d), of the Clean Water Act) is not subject to tracking requirements for that waste. However, generators of regulated medical waste with on-site incinerators are subject to DEM on-site incinerator requirements. (f) Generators of regulated medical waste with on-site treatment and/or destruction system(s) are subject to the requirements of Section 12.00 of these regulations. In addition, generators who treat and destroy regulated medical waste are subject to Sections 6.00, 7.00, 8.00, 9.00, and 10.00 of these regulations. Generators who treat or dispose of regulated medical waste on-site may also be subject to additional Federal, State, or local laws and regulations. (g) Training/Notification Requirement: Generators shall notify in writing all employees involved with the off-site transportation of regulated medical wastes of the provisions in Section 13.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 13.02 GENERAL REQUIREMENTS: Generators shall use transporters who have been issued a Rhode Island Regulated Medical Waste Transporter Permit number by the Rhode Island Department of Environmental Management, except as provided in Sections 13.02(b), (c), and (d) below. (a) Generators of Fifty (50) Pounds or More of Regulated Medical Waste Per Calendar Month: Generators who generate, transport, or offer for transport off-site fifty (50) pounds or more of regulated medical waste in a calendar month are subject to the requirements of Sections 6.00, 7.00, 8.00, 9.00, 10.00, 11.00 of these regulations and all requirements of this Section for each shipment of regulated medical waste. (b) Small Quantity Generator(s): Small Quantity Generators are subject to the requirements of Sections 6.00, 7.00, 8.00, 9.00, 10.00 and 11.00 of these regulations and are exempt from: -24- (1) The requirement to use a transporter who has been issued a Rhode Island Regulated Medical Waste Transporter Permit; and (2) The requirement to use a tracking form; and (3) The requirements of Section 13.03 of these regulations; (4) The exemption(s) contained in Sections 13.02(b)(1)-(b)(3) of these regulations shall only be applicable if the following conditions are met: (i) The regulated medical waste is transported to an intermediate handler or a destination facility with which the generator has a written agreement to accept the regulated medical waste; or the generator is transporting the regulated medical waste from the original generation point to a satellite facility or central collection point owned by the generator. (A) Small Quantity Generators who transport regulated medical waste between satellite facilities or to a central collection point shall apply for a variance, in accordance with Section 18.00 of these regulations, from: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 (B) Notwithstanding the requirements of Section 13.02(b)(4)(i) of these regulations, Small Quantity Generators in the same building may share a common storage facility within the building (before the waste is transported off-site), without applying for a variance; provided that the appropriate logs are kept at both the original generation point and the central collection point, as described in Section 13.05(b) of these regulations; and (C) Prior to utilization of a common storage facility pursuant to Section 13.02(b)(4)(i)(B) of these regulations, all participating Small Quantity Generators shall be signatories to a written agreement which describes, at a minimum, the person(s) responsible for preparing the Medical Waste Tracking Form, the person(s) responsible for arranging off- site transportation of regulated medical waste, and the person(s) assuming legal responsibility for any violation of these regulations. Not with-standing the foregoing, any written agreement must be approved in advance by the Director if the average total regulated medical waste generated per month is in excess of two hundred (200) pounds; and -25- (D) Other than Small Quantity Generators may act as the manager/ agent for agreements pursuant to Sections 13.02(b)(4)(i)(B) and (i)(C) of these regulations provided that: they are located in the same building as the participants; all regulated medical waste received under the agreement is segregated from their own regulated waste; and all regulated medical waste received under the agreement is transported off-site under a separate Medical Waste Tracking Form; and (ii) The regulated medical waste is transported by the generator, or an authorized employee, in a vehicle owned3 by the generator or authorized employee; and (iii) The generator shall compile a shipment log and maintain records as required in Section 13.05(b) of these regulations; and (iv) The generator submits semiannual reports to the Director. The generator may use a copy of the report form found in Appendix VIII or use any other type of report form as long as it includes the following information: (A) Name of Generator (company name); (B) Address of Generator; (C) Contact Person; (D) Telephone Number; (E) Generator Type4; (F) Quantity (by weight) of treated and untreated regulated medical waste transported off-site, during the reporting period, for which a medical waste tracking form was not used; and (G) Name and address of facility to which medical waste was transported. (5) Reports shall be submitted to the Director for the periods of January 1 to June 30 and July 1 to December 31 of each year.5 3Owned vehicle means a vehicle which is owned by or registered to the generator or employee or is under lease by the generator or authorized employee for a minimum of thirty (30) days. 4Hospital, Laboratory, Clinic, Physician, Dentist, Veterinarian, Long-Term or Residential Health Care Facility, Blood Bank, Mortician, or Other (Specify type) 5An initial report was required to be submitted for the period from the effective date of the -26- These reports shall be received by the Director within forty-five (45) days of the end of the reporting period. (c) Shipments Between Generator's Facilities: Generators are exempt from the requirement to use transporters that have a Rhode Island Regulated Medical Waste Transporter Permit number when transporting regulated medical waste from the original generation point to a central collection point, or between satellite facilities, provided they meet all of the following conditions: (1) The regulated medical waste is transported by the generator, or the generator's authorized employee, in a vehicle owned6 by the generator or the employee; and (2) The regulated medical waste is brought to a central collection point or treatment facility owned or operated by the generator. (i) Small Quantity Generators who transport regulated medical waste between satellite facilities shall apply for a variance, as per Section 18.00 of these regulations, from: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767; (ii) Other generators (i.e., those who generate and transport or offer for transport more than fifty (50) pounds of regulated medical waste in a calendar month) with multiple locations shall apply for a license or variance, as per Sections 4.00, 5.00, 8.00, 12.00, 14.00, 15.00 of these regulations from: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767; (3) The original generation point and the central collection point or treatment facility are located in the State of Rhode Island; and (4) The generator compiles and maintains a shipment log at each generation point and each central collection point as required by Section 13.05 of these regulations. regulations (14 April 1992) through 30 June 1992. 6Owned vehicle means a vehicle which is owned by or registered to the generator or employee or is under lease by the generator or authorized employee for a minimum of thirty (30) days. -27- (d) Shipments of Sharps and Unused Sharps Through the U.S. Postal Service and/or Private Courier Service: Small Quantity Generators who transport regulated medical waste (sharps and unused sharps) by the U.S. Postal Service and/or private courier service are exempt from the requirement to use a transporter that has a Rhode Island Regulated Medical Waste Transporter Permit number provided that the following conditions are met: (1) The package is sent certified mail, return receipt requested (indicating to whom the package was delivered, signature, date, and address where delivered). When a private courier service is utilized, this requirement shall be interpreted as requiring use of shipping options which: provide an initial receipt of acceptance from the private courier service, allow the package to be tracked in-transit, and provide the sender with a receipt which indicates to whom the package was delivered, signature of recipient, date received, and address where delivered; (2) The generator compiles a shipment log and maintains the original receipt and the returned registered mail receipt as required by Section 13.05 of these regulations; (3) The generator submits semiannual reports to the Director. The generator may use a copy of the report form found in Appendix VIII or use any other type of report form as long as it includes the following information: (i) Name of Generator (Company name); (ii) Address of Generator; (iii) Contact Person at Generator Facility; (iv) Telephone number; (v) Generator Type7; (vi) Quantity (by weight) of treated and untreated regulated medical waste sent by the U.S. Postal Service and/or private courier service, during the reporting period; and (vii) Name and address of facility to which medical waste was transported; 7Hospital, Laboratory, Clinic, Physician, Dentist, Veterinarian, Long-Term or Residential Health Care Facility, Blood Bank, Mortician, or Other (Specify type) -28- (4) Reports shall be submitted to the Director for the periods of January 1 to June 30 and July 1 to December 31 of each year.8 These reports shall be received by the director within forty-five (45) days of the end of each reporting period. 13.03 USE OF THE TRACKING FORM (a) Except as otherwise exempted in Section 13.02 of these regulations, a generator that transports or offers for transport regulated medical waste for off-site treatment or disposal shall prepare a tracking form according to this section and the instructions included in Appendix I. (b) Generators may obtain samples of the Rhode Island Medical Waste Tracking Form from: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade St. Providence, RI 02908-5767. (c) The generator shall prepare the number of tracking form copies that will provide the generator, each transporter(s), and each intermediate handler with one copy, and the owner or operator of the destination facility with two copies9. (d) The generator shall also: (1) Sign the certification statement on the tracking form by hand; (2) Obtain the handwritten signature of the initial transporter and include the date of acceptance on the tracking form; and (3) Retain one copy, in accordance with Section 13.05 of these regulations. (e) For rail shipments of regulated medical waste within the United States that originate at the site of generation, the generator shall send at least three (3) copies of the tracking form dated and signed in accordance with Section 13.03 of these regulations to: (1) The next non-rail transporter, if any; or (2) The intermediate handler or destination facility if transported solely by rail; or 8An initial report was required to be submitted for the period from the effective date of the regulations (14 April 1992) through 30 June 1992. 9The destination facility keeps one copy for its records and returns the second copy to the generator. -29- (3) The last rail transporter to handle the waste in the United States if exported by rail. 13.04 GENERATORS EXPORTING REGULATED MEDICAL WASTE: Generators, including transporters and intermediate handlers that initiate tracking forms, which export regulated medical waste to a foreign country for treatment and destruction, or disposal, shall request the destination facility to provide written confirmation that the waste was received. If the generator does not receive written confirmation from the destination facility within forty-five (45) days from the date of acceptance of the waste by the first transporter, the generator shall submit an exception report as required under Section 13.06 of these regulations. 13.05 RECORDKEEPING (a) Except as provided in Section 13.05(b) of these regulations, each generator shall: (1) Retain both the original generator receipt [yellow-copy 4] and the completed generator copy [white-copy 1] of each tracking form signed in accordance with Section 13.03 of these regulations, for at least three (3) years from the date the waste was accepted by the initial transporter; and (2) Retain for a period of three (3) years a copy of all exception reports required to be submitted under Section 13.06 of these regulations. (b) Generators that are exempt from using the Medical Waste Tracking Form, as specified in Section 13.02 of these regulations, shall meet the following requirements: (1) A shipment log shall be maintained at the original generation point for a period of three (3) years from the date the waste was shipped. The log shall contain the following information: (i) Date of shipment; (ii) Quantity (by weight) of regulated medical waste transported, by waste category (i.e., untreated and treated); (iii) Address or location of central collection point; (iv) Signature of generator's employee who is transporting the waste, to signify delivery has been completed. (2) A shipment log shall be maintained at each central collection point for a period of three (3) years from the date that regulated medical waste was accepted from each original generation point and shall contain the following information: -30- (i) Date of receipt; (ii) Quantity (by weight) of regulated medical waste accepted, by waste category (i.e., untreated and treated); (iii) Address or location of original generation point; and (iv) Signature of generator or generator's representative who operates the central collection point, to signify acceptance of the waste. (c) Generators that meet the conditions of Section 13.02(b) of these regulations and do not voluntarily comply with the use of the Medical Waste Tracking Form are subject to the following recordkeeping requirements: (1) Generators that use a transporter that holds a valid Rhode Island Regulated Medical Waste Transporter Permit shall maintain a log for a period of three (3) years from the date of shipment that contains the following information for each shipment or pickup: (i) Transporter's name and address; (ii) Transporter's Regulated Medical Waste Transporter Permit number; (iii) Quantity (by weight) of regulated medical waste transported, by waste category (i.e., untreated and treated); (iv) Date of shipment; and (v) The signature of the transporter's representative accepting the regulated medical waste for transport. (2) Generators that transport their own regulated medical waste to a treatment, destruction, or disposal facility as specified in Section 13.02(b)(4) of these regulations shall compile and maintain a log for a period of three (3) years from the date of the last shipment entered into the log. The log shall contain the following information: (i) Name and address of the intermediate handler, destination facility, or health care facility to which the generator has transported the shipment of regulated medical waste; (ii) Quantity (by weight) of regulated medical waste transported, by waste category (i.e., untreated and treated); (iii) Date of shipment; and (iv) Signature of the generator or his authorized representative who transported the waste. -31- (3) Generators that transport regulated medical waste by the U.S. Postal Service and/or private courier service under Section 13.02(d) of these regulations shall retain the original U.S. Postal Service and/or private courier service receipt and the return mail receipt and maintain a shipment log for a period of three (3) years from the date of shipment. The log shall contain the following information: (i) Quantity (by weight) of regulated medical waste transported, by waste category (i.e., untreated and treated); (ii) Date of shipment; and (iii) Name and address of each intermediate handler or destination facility to which the generator has transported the regulated medical waste by the U.S. Postal Service and/or private courier service. 13.06 EXCEPTION/DISCREPANCY REPORTING (a) A generator that meets the conditions of Section 13.02(a) of these regulations or initiates a tracking form voluntarily shall contact the owner or operator of the destination facility, transporter(s), and intermediate handler(s), as appropriate, to determine the status of any tracked waste if he does not receive a copy of the completed tracking form with the handwritten signature of the owner or operator of the destination facility within thirty-five (35) days of the date the waste was accepted by the initial transporter. (b) A generator shall submit an Exception Report, as described below, to the Director if he has not received a completed copy of the tracking form signed by the owner or operator of the destination facility within forty-five (45) days of the date the waste was accepted by the initial transporter. The Exception Report shall be postmarked on or before the forty-sixth (46th) day and shall include: (1) A legible copy of the original tracking form for which the generator does not have confirmation of delivery; and (2) A cover letter signed by the generator or his authorized representative explaining the efforts taken to locate the regulated medical waste and the results of those efforts. (3) A copy of the exception report shall be kept by the generator for a period of at least three (3) years from the due date of the report. (c) A generator shall also submit a Discrepancy Report, as described below, to the Director if there are any discrepancies between the information contained on the original generator receipt [yellow-copy 4] and the signed/completed generator copy [white-copy 1] that are not documented in Block 23 of the Medical Waste Tracking Form. This Discrepancy Report shall be postmarked no later than five (5) working days from the date that the signed/completed -32- generator copy [white-copy 1] is received from the owner or operator of the destination facility and shall include: (1) A legible copy of both the original generator receipt and the signed/ completed generator copy received from the owner or operator of the destination facility; and (2) A cover letter signed by the generator or his authorized representative identifying the discrepancies that were not documented in Block 23 of the Medical Waste Tracking Form; (3) A copy of this Discrepancy Report shall be kept by the generator for a period of at least three (3) years from the date of the report. 13.07 SMALL QUANTITY GENERATOR REPORTING (a) A Small Quantity Generator that is exempt from using the tracking form according to the conditions specified in Sections 13.02(b), 13.02(c), or 13.02(d) of these regulations and that maintains shipment logs as specified in Section 13.05(b) of these regulations shall submit semiannual reports to the Director. (b) The generator may use a copy of the report form found in Appendix VIII or use any other type of report form as long as it includes the following information: (1) The generators name, address, and type of facility; (2) The name and telephone number of a contact person; (3) The name and address of the facilities to which medical waste was transported; (4) The quantity of treated regulated medical waste transported to each facility; (5) The quantity of untreated regulated medical waste transported to each facility; and (6) The dates of the reporting period. (c) The reports shall be submitted to the Director for the periods of January 1 to June 30 and July 31 to December 31 of each year.10 (d) Generators shall submit these reports required in Section 13.07(a) of these regulations within forty-five (45) days of the end of the reporting period. 10An initial report was required to be submitted for the period from the effective date of the regulations (14 April 1992) through 30 June 1992. -33- 13.08 ADDITIONAL REPORTING: The Director may require generators to furnish additional information concerning the quantities and management methods of medical waste as deemed necessary under the Resource Conservation and Recovery Act, Section 11004. 14.00 TRANSPORTER REQUIREMENTS FOR OFF-SITE TRANSPORTATION OF REGULATED MEDICAL WASTE 14.01 APPLICABILITY (a) These requirements apply to transporters and owners and operators of transfer facilities engaged in transporting regulated medical waste in Rhode Island. No person or other legal entity shall engage in the transportation of regulated medical waste in or on the land or waters of Rhode Island unless such person or entity shall first have been issued a permit by the Director for this purpose. (b) Notwithstanding the requirements of Section 14.03(a) of these regulations, the following are exempt from the requirements of this section: (1) Generators of regulated medical waste that transport regulated medical waste but are exempt under Section 13.02(b) of these regulations from the requirement for initiating a Medical Waste Tracking Form; and (2) Persons transporting household medical waste; and (3) On-site transportation of regulated medical waste. (c) A transporter of regulated medical waste shall also comply with Section 13.00 of these regulations when the transporter consolidates two or more shipments of regulated medical waste onto a single tracking form. (d) Transporters shall also comply with Sections 6.00, 7.00, 8.00, 9.00, and 11.00 of these regulations if the transporters: (1) Store regulated medical waste in the course of transport; or (2) Remove regulated medical waste from a reusable container; or (3) Modify packaging of regulated medical waste. (e) Transporters shall not accept regulated medical waste from a generator unless and until said generator has a valid Regulated Medical Waste Generator Registration Number issued pursuant to Section 16.00 of these regulations. (f) Training/Notification Requirement: Transporters and owners and operators of transfer facilities shall notify in writing all employees involved with off-site transportation of regulated medical waste of the provisions in this -34- Section 14.00 of these regulations. Generators shall notify in writing all employees involved with the off-site transportation of regulated medical waste of the provisions of Sections 6.00, 7.00, 8.00, 9.00, 11.00 and 14.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 14.02 EPA TRANSPORTER NOTIFICATION: If EPA adopts regulations requiring transporters to notify EPA prior to transporting regulated medical waste, such transporters shall comply with these EPA requirements and obtain an EPA identification number prior to receiving a Rhode Island Regulated Medical Waste Transporter Permit, as described in Section 14.03 of these regulations. 14.03 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 (Appendix V). 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) The following information for each vehicle that may be used to transport regulated medical waste: (i) The manufacturer; -35- (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; (8) 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 14.03(b)(7) of these regulations; (9) Location(s) to be used, pursuant to Section 14.12 of these regulations, for temporary storage of regulated medical waste in vehicles; (10) 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; (11) A copy of the applicant's Spill Management Plan prepared in accordance with the requirements of Section 14.08 of these regulations; (12) The permit application fee specified by Section 14.03(f)(1) of these regulations; (13) The signature of the applicant or a person duly authorized to act on behalf of the applicant; and (14) 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 14.00 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. -36- (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 -37- (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 14.03(d) of these regulations shall be inspected by the Director, to demonstrate compliance with all applicable requirements of these regulations, in accordance with the following schedule: (1) Prior to the issuance of any Regulated Medical Waste Transporter Permit; and (2) Annually prior to the first and second anniversaries of the issuance date of a Regulated Medical Waste Transporter Permit. (3) The holder of a Regulated Medical Waste Transporter Permit shall submit a written request for an annual inspection to the Director at least thirty (30) days, and no more than sixty (60) days, prior to the first and second anniversaries of the issuance date of said permit. (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 ($100) per vehicle identified on the permit application; (2) An annual inspection fee of ($100) per vehicle identified on the permit application; (3) No permit fee adjustments shall be made for vehicles which are removed from the permit and not replaced. (g) 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 Transporter Permit shall expire three (3) years from the date of issuance, unless sooner modified, suspended or revoked. However, the permit holder shall be required to pay the annual application fee specified by Section 14.03(f)(2) of these regulations no later than one (1) year and two (2) years from the date of issuance to maintain the permit in force for the full three (3) year issuance period. (i) Renewal of Regulated Medical Waste Transporter Permits -38- (1) Requests for renewal of a Regulated Medical Waste Transporter Permit shall contain all the information required by Section 14.03 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. 14.04 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 7.00 of these regulations and Labeled/Marked in accordance with Section 11.00 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 13.03 of these regulations unless the generator is exempt from the use of the tracking form under Section 13.02 of these regulations. (c) Notwithstanding Section 14.04(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 the weight in pounds11 of all treated and untreated regulated medical waste accepted; 11Treatment, destruction and destination facilities will be required to confirm that the actual weight of any single container of regulated medical waste differs from its listed weight by no more than ten percent (10%), and that the actual weight of all containers in a shipment of regulated medical waste differs from the total weight listed on the Medical Waste Tracking Form by no more than five percent (5%). -39- (2) On all copies of the tracking form, sign and indicate the date the waste was accepted by 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. 14.05 USE OF THE MEDICAL WASTE TRACKING FORM (a) A transporter, other than a rail transporter, shall ensure that the tracking form accompanies the regulated medical waste during transport. (b) When a transporter, other than a rail transporter, delivers regulated medical waste to another transporter or a destination facility, the delivering transporter shall: (1) On all copies of the tracking form, obtain the date of delivery and the handwritten signature of the accepting transporter or the operator of the destination facility; (2) Retain one copy of the signed and dated tracking form; and (3) Give the remaining copies of the signed and dated tracking form to the accepting transporter or to an authorized facility representative. (c) When a transporter, other than a rail transporter, delivers regulated medical waste to a transporter outside Rhode Island or facility outside Rhode Island, the delivering transporter shall: (1) Verify that the waste has been delivered to the accepting transporter or operator of the facility; (2) On all copies of the tracking form, have the accepting transporter or facility operator write his signature and the date he accepts the waste, or if the accepting transporter or facility operator will not provide his signature, the delivering transporter shall write his own signature and the date he delivers the waste; (3) Retain one copy of the signed and dated tracking form; and (4) Give the remaining copies of the tracking form to the accepting transporter, intermediate handler, or destination facility. -40- (d) Delivery of Regulated Medical Waste Outside the United States: Any transporter who transports regulated medical waste across an international border, or who delivers regulated medical waste to a transporter or treatment, destruction, or destination facility located in a foreign country shall: (1) Sign the tracking form and verify that the waste has been delivered to the next transporter, or treatment, destruction, or destination facility; (2) Retain one copy of the signed tracking form for his records; and (3) Return all remaining copies of the tracking form by mail to the generator. (e) Consolidating or Remanifesting Waste to a New Tracking Form (1) Transporters shall complete a tracking form for all regulated medical waste received from generators who meet the conditions of Section 13.02(b) of these regulations (i.e., in shipments of less than fifty (50) pounds that are not accompanied by a tracking form). (2) A transporter may choose to consolidate or remanifest to a single tracking form all shipments of regulated medical waste less than two hundred and twenty (220) pounds12. (3) When the transporter receives the signed tracking form, that was initiated by the transporter, from the destination facility, and the regulated medical waste was accompanied by a tracking form originated by a generator, the transporter shall: (i) Attach a copy of the tracking form signed by the destination facility to the generator's original tracking form; and (ii) Retain a copy of each tracking form in accordance with Section 14.13 of these regulations; and (iii) Return a copy of each tracking form to the generator within thirty- five (35) days of the date that the generator offered the documented regulated medical waste for transport; (4) For each tracking form initiated, either by accepting waste from generators who meet the conditions of Section 13.02(b) of these regulations or by consolidating tracking forms onto a new one, the transporter shall maintain a consolidation log indicating all shipments 12DEM strongly recommends that, to minimize bookkeeping errors, transporters consolidate or remanifest those shipments from generators who are required to originate the tracking form separately from those shipments by generators who are not required to originate the tracking form. -41- consolidated or remanifested on that form. The log shall accompany the tracking form and include the following information: (i) Name of each generator; (ii) The generator's address; (iii) Date the regulated medical waste was originally shipped by the generator; (iv) Quantity of regulated medical waste (i.e., number of containers and weight in pounds) by waste category (i.e., "untreated" or "treated") shipped by each generator; and (v) The names, Regulated Medical Transporter Permit or identification numbers of all previous transporters or, if not applicable, the transporters' addresses. (f) Special Requirements for Waste from Small Quantity Generators: A transporter accepting a shipment from a Small Quantity Generator need not comply with the requirements of Sections 14.05(a) through 14.05(e) of these regulations provided that: (1) The transporter compiles a log, containing the following information for each shipment of regulated medical waste: (i) The generator's name and address; (ii) The quantity of waste accepted (number of packages and total weight by waste category (i.e., "untreated" and "treated"); and (iii) The date the waste is accepted; (2) The transporter carries this log in the vehicle while transporting such regulated medical waste to a second transporter; (3) The transporter dates and signs the generator's log required under Section 13.05(b) of these regulations; and (4) The transporter complies with Section 14.05(e) of these regulations. (g) When a transporter receives from a treatment, destruction or destination facility a copy of a tracking form which he initiated pursuant to Section 14.05(e) of these regulations, and which the operator of such facility signed and dated in accordance with Section 14.05(c)(2) of these regulations, such transporter shall: (1) Attach a copy of the tracking form received from the treatment, destruction, or destination facility to the copy of the tracking form originally prepared by the generator; -42- (2) Retain a copy of the tracking form received from said facility; and (3) Return a copy of the tracking form received from the facility, together with a copy of the tracking form originally prepared by the generator, to the generator so that the generator receives these tracking forms within thirty-five (35) days of the date that the generator offered the documented regulated medical waste for transport. (h) For each tracking form initiated pursuant to Section 14.05(e) of these regulations, a transporter shall compile a consolidation log reflecting all shipments of regulated medical waste consolidated on that form. The consolidation log shall accompany the tracking form during transportation of the waste and shall contain the following information for each shipment: (1) Name and address of generator; (2) Date on which the shipment was accepted by such transporter; (3) Number of containers and the weight in pounds of all treated and untreated regulated medical waste in the shipment; and (4) Name, address, and Rhode Island Regulated Medical Waste Transporter Permit number of each previous transporter, if any. (i) When a non-rail transporter accepts regulated medical waste from a rail transporter, such non-rail transporter shall: (1) Write his signature and the date he accepts the waste on all copies of the tracking form which was forwarded by the generator or 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) Leave a copy of the signed and dated shipping paper with the rail transporter, if applicable; and (3) Retain a copy of the signed and dated shipping paper or tracking form, as applicable. 14.06 MARKING (IDENTIFICATION) (a) When regulated medical waste is handled by more than one transporter, each subsequent transporter shall attach a water resistant identification tag below the generator's marking on the outer surface of the packaging, so that it does not obscure the generator's or previous transporter's markings. The transporter taking possession of the shipment shall ensure that the tag contains the following information: (1) Name of transporter taking possession (receiving) of the regulated medical waste; -43- (2) Transporter Regulated Medical Waste Transporter Permit number and; (3) Date of receipt. 14.07 DELIVERY OF REGULATED MEDICAL WASTE (a) A transporter shall deliver the entire quantity of regulated medical waste that he accepts from a generator or prior transporter to: (1) The destination facility identified on the tracking form, or (2) The next transporter, if any. (b) If regulated medical waste cannot be delivered in accordance with Section 14.07(a) of these regulations, a medical waste transporter shall: (1) Contact the generator for further directions; (2) Revise the tracking form according to the generator's instructions; and (3) Deliver the entire quantity of regulated medical waste according to the generator's instructions. (c) No transporter shall deliver regulated medical waste or cause regulated medical waste to be delivered to any treatment, destruction or destination facility , whether located inside or outside of Rhode Island, unless such treatment and/or destruction facility complies with all applicable law. (d) If any vehicle owned or operated by a medical waste transporter is involved in a spill of regulated medical waste or if the vehicle is involved in an accident which renders the vehicle in non-compliance with Section 14.00 of these regulations, such transporter shall immediately notify the Director of DEM. 14.08 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 -44- 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 14.08(c) of these regulations and be effective against mycobacteria; (iii) Fifty (50) plastic infectious waste bags that meet the requirements of Section 7.04 of these regulations, accompanied by sealing tape (or devices for sealing), and appropriate labels as required by Section 11.00 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 14.08 of these regulations. (c) Disinfectants and Decontamination Procedures -45- (1) Approved routine decontamination procedures for soiled surfaces include, but are not limited to: (i) Exposure to hot water of at least 82 oC (180 oF) 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 14.08(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 14.08(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 on forms provided by the Director for this purpose (see Appendix VI). 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. 14.09 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 14.08 of these regulations, or permit the Department to decontaminate at the owner's -46- 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. 14.10 PERSONNEL/EQUIPMENT (a) The transporter of regulated medical waste shall provide a sufficient number of personnel with the skills necessary to comply with all applicable laws and regulations. (b) All equipment shall be maintained in such a manner that it shall be fit for the purposes for which it was intended by the manufacturer. 14.11 CONTAINERIZATION OF REGULATED MEDICAL WASTE: The transporter of regulated medical waste shall not handle containerized regulated medical waste unless the containers are constructed and maintained in accordance with these regulations and the medical waste is properly segregated, packaged, labeled, and marked in accordance with Sections 6.00 and 7.00 of these regulations. 14.12 TEMPORARY STORAGE: A medical waste transporter may store regulated medical waste in the same vehicle used to pick up and transport such waste from a generator only if: (a) Such vehicle is parked at a location that: (1) Is under the direct control of the transporter; and (2) Has been approved for such use by the Director in the transporter's Regulated Medical Waste Transporter Permit; (b) The location where such vehicle is parked is secured to prevent access thereto by any person other than the transporter and the transporter's employees; (c) Such vehicle is parked at such location for no longer than forty-eight (48 consecutive hours, excluding weekends and State holidays; (d) The regulated medical waste is stored in accordance with the provisions of Section 8.00 of these regulations; (e) Such vehicle complies with the provisions of Section 14.03(e) of these regulations; (f) No regulated medical waste is loaded on to or off of such vehicle during storage of regulated medical waste; (g) Temporary storage of regulated medical waste shall only be allowed in locations approved by the Director and included on the application for a Regulated Medical Waste Transporter Permit; -47- (h) Temporary storage in the transporting vehicle at the location of a breakdown of the vehicle shall only be allowed if the transporter notifies the Department of the location of the vehicle and the estimated time for repairs. During the period of the break down, the cargo body of the vehicle shall be locked and shall not be accessible to anyone except authorized personnel; (i) Temporary storage facilities shall keep an accurate log of all regulated medical waste shipped in and out of the facility; and (j) Medical waste transfer stations shall be in accordance with Rhode Island General Laws 23-19.12 and these regulations, and be licensed in accordance with all applicable rules and regulations. 14.13 RECORDKEEPING (a) A transporter of regulated medical waste shall keep a copy of the tracking form signed by the generator, the previous transporter (if applicable), and the next party, which may be one of the following: another transporter; or the owner or operator of an intermediate handling facility; or destination facility. The transporter shall retain a copy of this form for a period of three (3) years from the date the waste was accepted by the next party. (b) For regulated medical waste that is not accompanied by a generator-initiated tracking form, the transporter shall retain a copy of all transporter-initiated tracking forms and consolidation logs for a period of three (3) years from the date the waste was accepted by the transporter. (c) For any regulated medical waste that was received by the transporter accompanied by a tracking form and consolidated or remanifested by the transporter to another tracking form, the transporter shall: (1) Retain a copy of the generator-initiated tracking form signed by the transporter for a period of three (3) years from the date the waste was accepted by the transporter; and (2) Retain a copy of the transporter-initiated tracking form signed by the intermediate handler or destination facility for a period of three (3) years from the date the waste was accepted by the intermediate handler or destination facility. (d) Retain a copy of each transporter report required by Section 14.14 of these regulations for a period of three (3) years from the date of submission. 14.14 REPORTING: A transporter that accepts regulated medical waste generated in Rhode Island shall submit reports describing the source and disposition of the waste. In addition, transporters that accept regulated medical waste generated in another state shall submit reports describing the source and disposition of the waste if such waste is being transported to a destination -48- facility, intermediate handler, or transfer facility located in Rhode Island. The reports shall be submitted using the form in Appendix III of these regulations. (a) Transporters regulated under this section shall also comply with any applicable Federal medical waste transporter reporting requirements. (b) One copy of the report described in Section 14.14(c) of these regulations shall be submitted to: Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, Rhode Island 02908-5767. (c) Each report shall contain the following information in the format provided by Appendix III: (1) The transporters name, address, and RI Regulated Medical Waste Transporter Permit number; (2) The name and telephone number of a contact person; (3) Total number of generators from whom the transporter accepted regulated medical waste; (4) The name, address, and type of each generator from whom the transporter accepted regulated medical waste; (5) The amount by weight and waste category (i.e., untreated or treated) of regulated medical waste accepted from each generator; (6) The total, by weight and waste category, of regulated medical waste from all generators in Rhode Island that the transporter delivered to an intermediate handler or to a destination facility; (7) The total, by weight and waste category, of regulated medical waste from all generators in Rhode Island that the transporter delivered to a second transporter or to a transfer facility; and (8) The certification signed by the owner or operator, or his authorized representative. (d) Transporters that transport or deliver regulated medical waste to an intermediate handler or to a destination facility shall also provide the following information: (1) The name and address of each intermediate handler and destination facility to which waste from Rhode Island was delivered; (2) The amount, by waste category, that was delivered; -49- (3) The total number of intermediate handlers and destination facilities to which waste was delivered. (e) The transporter shall submit reports for the periods of January 1 to June 30 and July 1 to December 31 of each year.13 (f) Transporters shall submit the reports required in Section 14.14(e) on or before the date forty-five (45) days after the end of the reporting period. (g) Each transporter that initiates a tracking form shall meet the requirements of Section 13.06 of these regulations (Exception Reporting), except that the thirty-five (35) and forty-five (45) day periods commence on the day the transporter accepted the waste from the generator. 14.15 RAIL SHIPMENTS OF REGULATED MEDICAL WASTE (a) Applicability: These requirements apply to persons engaged in rail transportation of regulated medical waste generated in Rhode Island. (b) Rail transporters of regulated medical waste shall also comply with all other parts of Section 14.00 of these regulations, except as otherwise noted in these regulations. (c) General Requirements: The following requirements apply to all shipments of regulated medical waste involving rail transport: (1) When accepting regulated medical waste generated in Rhode Island from a non-rail transporter, the initial rail transporter shall: (i) Sign and date the tracking form acknowledging acceptance of the regulated medical waste; (ii) Return a signed copy of the tracking form to the non-rail transporter; (iii) Forward at least three copies of the tracking form to: (A) The next non-rail transporter, if any; or (B) The intermediate handler or destination facility, if the shipment is delivered to that facility by rail; or (C) The last rail transporter designated to handle the waste in the United States; and (iv) Retain one copy of the tracking form and rail shipping paper in accordance with Section 14.05 of these regulations. 13An initial report was required to be submitted for the period from the effective date of the regulations (14 April 1992) through 30 June 1992. -50- (2) A rail transporter shall ensure that a shipping paper accompanies each shipment of regulated medical waste during transport and contains all the information required on the tracking form, other than that required by Boxes 7, 10, and 15. A rail transporter that accepts regulated medical waste from a prior rail transporter and delivers such waste to a subsequent rail transporter is not required to sign the shipping paper relating to such shipment of waste. (3) When a rail transporter delivers regulated medical waste to a treatment or destination facility in Rhode Island, such transporter shall: (i) Have the operator of the destination facility who has accepted the regulated medical waste sign and date all copies of the tracking form which was forwarded by the generator or the first non-rail transporter to the destination facility, or, if the tracking form has not been received by the treatment or destination facility, on the shipping paper; and (ii) Retain a copy of the signed and dated tracking form or shipping paper, as applicable. (4) When delivering regulated medical waste to a non-rail transporter, a rail transporter shall: (i) Obtain the date of delivery and the handwritten signature of the next non-rail transporter on the tracking form; and (ii) Retain a copy of the tracking form in accordance with Section 14.13 of these regulations. (5) Upon accepting regulated medical waste generated in Rhode Island from a rail transporter, a non-rail transporter shall sign and date the tracking form (or the shipping papers if the tracking form has not been received by the transporter) and provide a copy to the rail transporter. 14.16 ADDITIONAL REPORTING: The Director may require transporters to furnish additional information concerning the quantities and management methods of regulated medical waste as deemed necessary under the Federal Resource Conservation and Recovery Act (RCRA) Section 11004. 15.00 TREATMENT, DESTRUCTION AND DESTINATION FACILITIES 15.01 APPLICABILITY: The provisions of this Section apply to owners and operators of facilities that treat, destroy, and/or dispose of regulated medical waste as follows: (a) Destination facilities; -51- (b) Intermediate handlers; (c) Generators that receive regulated medical waste accompanied by a tracking form. (d) Persons that treat and/or destroy regulated medical waste that has been generated on-site, and do not treat and/or destroy regulated medical waste that has been generated off-site, shall only be exempt from the provisions of Sections 15.02(a), 15.02(b), 15.03, 15.04 and 15.05 of these regulations. 15.02 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 7.00 and 11.00 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 13.00 and 14.00 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 14.08(c) of these regulations and be effective against mycobacteria. (3) Fifty (50) red plastic infectious waste bags that meet the requirements of Section 7.04(c) of these regulations, accompanied by sealing tape (or devices), and appropriate labels as required by section 11.00 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. -52- (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 14.08 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. -53- 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 nonputrescent 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. -54- (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 15.02 (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 15.02 (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 15.02(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 15.02(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 15.00 of these regulations. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials. 15.03 USE OF THE TRACKING FORM (a) Destination Facility: When a destination facility receives regulated medical waste accompanied by a tracking form, the owner or operator shall: (1) Sign and date each copy of the tracking form to certify that the regulated medical waste listed on the tracking form was received; (2) Note any discrepancies as defined in Section 15.04 of these regulations on the tracking form; -55- (3) Immediately give the transporter at least one copy of the signed tracking form; (4) Send a copy of the tracking form to the generator (or to the transporter or intermediate handler that initiated the tracking form) within fifteen (15) days of the delivery; (5) Retain a copy of each tracking form in accordance with Section 15.05(a) of these regulations. (b) Intermediate Handlers: When an intermediate handler receives regulated medical waste accompanied by a tracking form, the owner or operator shall meet the following requirements: (1) The owner or operator shall initiate a new tracking form for each shipment of regulated medical waste that has either been treated or destroyed. The owner or operator shall also meet all the requirements for generators under Sections 6.00 through 13.08 of these regulations including signing the tracking form, indicating the acceptance of the waste as specified in Box 20, and entering the new tracking form number in Box 21. (2) The owner or operator shall maintain a log matching the original generator's tracking forms to the tracking form that the owner/operator shall initiate. This log shall include: (i) Name(s) of generator(s); (ii) Generator's address; (iii) The date the regulated medical waste was originally shipped by the generator or the generator's unique tracking form number; (iv) The new tracking form number to which the waste is assigned; (3) Within fifteen (15) days of receipt of the tracking form that was initiated by the owner/operator and that was signed by the destination facility, the intermediate handler shall: (i) Attach a copy of the tracking form, signed by the destination facility, to the original tracking form initiated by the generator according to Section 13.03 of these regulations; (ii) Send a copy of each tracking form to the generator that initiated the tracking form; and (iii) Retain a copy of each tracking form in accordance with the requirements of Section 14.13 of these regulations. -56- (c) Rail Shipments: If a destination facility or intermediate handler receives regulated medical waste from a rail transporter that is accompanied by shipping papers containing the information required on the medical waste tracking form, with the exception of the generator's certification and chain of custody signatures, the owner or operator or his agent, shall: (1) Sign and date each copy of the tracking form or the shipping papers (if the tracking form has not been received); (2) Note any discrepancies, as defined in Section 15.04 of these regulations, on each copy of the tracking form or shipping papers (if the tracking form has not been received); (3) Immediately give the rail transporter at least one copy of the tracking form or shipping papers (if the tracking form has not been received); (4) (i) If the facility is a destination facility, send a copy of the signed and dated tracking form to the generator within fifteen (15) days after the delivery. If the owner or operator has not received the tracking form within fifteen (15) days of delivery, a copy of the signed and dated shipping papers shall be sent to the party initiating the tracking form; (ii) If the facility is an intermediate handler, retain a copy of the tracking form (or the shipping papers if the tracking form has not been received), until a copy of the tracking form signed by the owner or operator of the destination facility. The destination facility or intermediate handler shall then: (A) Attach a copy of the tracking form (signed by the destination facility) to the original tracking form (or the shipping papers if the tracking form has not been received) initiated by another party; (B) The intermediate handler and destination facility shall send a copy of each tracking form (or each set of shipping papers) to the party who initiated the tracking form; and (C) The intermediate handler and destination facility shall retain a copy of each tracking form in accordance with the requirements of Section 15.05 of these regulations. (5) The intermediate handler and destination facility shall retain a copy of the tracking form (or shipping papers if signed in lieu of the tracking form) for at least three (3) years from the date of acceptance of the regulated medical waste14. 14Destination facilities and intermediate handlers receiving shipments by rail should receive the tracking form from the generator, or the preceding non-rail transporter that will have sent the tracking form to the facility by some other means (e.g., by mail). -57- 15.04 TRACKING FORM DISCREPANCIES (a) Tracking form discrepancies are: (1) For Containers: (i) Any variation in piece count such as a discrepancy of one box, pail, or drum in a truckload; or (ii) Any variation in the actual weight of any single container of regulated medical waste that differs from its listed weight by more than ten percent (10%); or (iii) Any variation in the actual weight of all containers in a shipment of regulated medical waste that differs from the total weight listed on the Medical Waste Tracking Form by more than five percent (5%). (2) For Waste by Categories (i.e., Untreated or Treated): Discrepancies in number of containers for each category of regulated medical waste as described on the label imprinted or affixed to the outer surface of the package; (3) For packaging that is broken, torn, or leaking; and (4) Regulated medical waste that arrives at an intermediate handler or a destination facility unaccompanied by a tracking form, where the owner or operator knows such form is required, or for which the tracking form is incomplete or not signed. (b) Upon discovering a discrepancy, the owner or operator of the treatment, destruction, or destination facility shall attempt to resolve the discrepancy with the waste generator, the transporter and/or the intermediate handler. If the discrepancy is not resolved, the owner or operator shall submit a letter, within fifteen (15) days of receiving the waste, to the Director. The letter shall describe the nature of the discrepancy and the attempts the owner or operator has undertaken to reconcile it. The owner or operator shall include a legible copy of the tracking form or shipping papers in question with the letter. If the discrepancy is the type specified in Section 15.04(a)(4) of these regulations, the report shall specify the quantity of waste received, the transporter, and the generator(s). 15.05 RECORDKEEPING (a) The owner or operator of a destination facility or an intermediate handler receiving regulated medical waste shall maintain records for a minimum of three (3) years from the date the waste was accepted. These records shall contain the following information: -58- (1) Copies of all tracking forms and logs required by these regulations; and (2) The name and address of each generator that delivered waste to the destination facility or intermediate handler under Section 13.02(b) of these regulations, and the generator's address; and (3) Copies of all discrepancy reports required by Section 15.04 of these regulations. (b) The owner or operator of a destination facility or an intermediate handler that accepts regulated medical waste from generator(s) subject to Section 13.02 (b) of these regulations shall maintain the following information for each shipment of regulated medical waste accepted: (1) The date the waste was accepted; (2) The name and address of the generator who originated shipment; (3) The total weight of the regulated medical waste accepted from the originating generator; and (4) The signature of the individual accepting the waste. 15.06 ADDITIONAL REPORTING: The Director may require owners or operators of treatment, destruction, or destination facilities to furnish additional information concerning the quantities and management methods of medical waste as deemed necessary under the Federal Resource Conservation and Recovery Act (RCRA) Section 11004 or under these regulations. 15.07 TREATMENT, DESTRUCTION, AND DISPOSAL OF REGULATED MEDICAL WASTES (a) Regulated medical waste remains subject to the handling and management requirements of these regulations and to any relevant Federal regulations until the regulated medical waste is both treated and destroyed. (b) Once regulated medical waste has been both treated and destroyed, its residue may be disposed of as non-regulated medical waste unless that residue meets the definition of hazardous waste as defined by DEM Rules and Regulations for Hazardous Waste Management. Untreated regulated medical waste may be transported off-site for treatment and destruction, treated on-site and transported off-site for destruction, or treated and destroyed on-site. Regulated medical waste shall not undergo mechanical destruction before it has been treated, unless the mechanical destruction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste. -59- (c) Treatment and destruction combinations that fulfill the requirements for proper treatment and destruction of regulated medical wastes include, but are not limited to, the following: (1) For Liquid Regulated Medical Wastes, Including Body Fluids, Human Blood and Blood Products: Acceptable disposal methods include: (i) Incineration; (ii) With approval15, discharge into a sanitary sewer system that has a secondary wastewater treatment facility. Methods of discharge shall be limited to: (A) Direct discharge into the sanitary sewer system; (B) Discharge after steam sterilization; or (C) Discharge after chemical disinfection with a one-to-ten (1:10) dilution of five percent (5%) sodium hypochlorite solution or equivalent chemical disinfection. (iii) Discharge into an Individual Sewage Disposal System (ISDS), provided that chemical disinfectants and/or preservatives are not added to the body fluids, human blood and/or blood products prior to discharge and that no more than ten (10) gallons of body fluids, human blood and/or blood products are discharged in an ISDS during a twenty-four (24) hour period; (2) For Human Pathological Wastes (Not Including Body Fluids) and Animal Pathological Wastes: Acceptable technologies include: (i) Incineration. (3) For Sharps and Unused Sharps: Acceptable technologies include: (i) Incineration; (ii) Chemical disinfection, utilizing chemicals specifically approved by EPA/FIFRA for disinfection of medical waste, with or followed by grinding or shredding; and (iii) Steam sterilization followed by grinding or shredding. 15The discharge of liquid wastes into a sanitary sewer system requires written approval from the Local Sewer Authority/Commission pursuant to the provisions of Section 46-12-3 of the General Laws of Rhode Island and the "Rhode Island Pretreatment Regulations" of DEM. In addition, the discharge of such liquid waste may be subject to other pretreatment requirements of the Local Sewer Authority/Commission. -60- (4) For Other Regulated Medical Wastes (Including, But Not Limited To, Cultures and Stocks, Items Saturated and/or Dripping and/or Caked With Human Blood): Acceptable technologies include: (i) Incineration; (ii) Chemical disinfection, utilizing chemicals specifically approved by EPA/FIFRA for disinfection of medical waste, with or followed by grinding or shredding; (iii) Steam sterilization followed by grinding or shredding. (d) Alternative Technologies: Any other treatment, destruction and/or disposal technology shall only be utilized if such treatment, destruction and/or disposal technology has been approved in writing by the Director. (e) Approval of Alternative Technologies: (1) The Director shall not grant approval for the use of any other combination of treatment, destruction and/or disposal technologies, unless and until such technologies are proven, on the basis of thorough tests to: (i) Completely and reliably inactivate vegetative bacteria, fungi, viruses, parasites, and mycobacteria at a 6 Log10 reduction or greater; and (ii) Completely and reliably inactivate Bacillus stearothermophilus spores or Bacillus subtilis spores at a 4 Log10 reduction or greater; and (iii) Be protective with respect to total impact on the environment; and (iv) Ensure the health, safety and welfare of both facility employees and the general public; and (v) Ensure that the total weight and/or volume of the endproduct of the alternative technology does not exceed the total weight and/or volume of the regulated medical waste prior to treatment and/or destruction. (2) Notwithstanding the provisions of Paragraph 15.07(e)(1) of these regulations, the Director may deny any application for just cause within the scope and intent of these regulations. 16.00 REGISTRATION FOR GENERATORS OF REGULATED MEDICAL WASTE 16.01 GENERAL REQUIREMENTS (a) No person whose primary business activity of purpose is the diagnosis (including testing and laboratory analysis), treatment, or immunization of -61- human beings or animals, in research pertaining thereto, or in the preparation of human remains for burial or cremation, or in the production or testing of biologicals, or in the development of pharmaceuticals shall engage in the generation of regulated medical waste unless that person shall have registered with the Director in accordance with the requirements contained in Section 16.01(b) of these regulations and have been issued a Regulated Medical Waste Generator Registration Number. For the purpose of these regulations, a person is considered to be a single generator, even if it utilizes more than one (1) site in the course of its operation. (b) Contents of Application: A generator shall submit an application for a Regulated Medical Waste Generator Registration Number on a form prescribed by the Director (Appendix IX). Such application shall include, as a minimum, the following: (1) Name under which the application is being made; (2) Business location(s) used to generate regulated medical waste, and mailing address if different from generation location(s); (3) The type16 of generator facility at each business location; (4) Applicant's business phone number; (5) The name and phone number of the primary contact person for the facility; (6) The approximate amount of regulated medical waste (in pounds) that will be generated per year at each location; (7) If regulated medical waste is to be treated and/or destroyed on-site, provide a description of the treatment/destruction methods; (8) If regulated medical waste is to be transported off-site for treatment and/or destruction, provide the approximate quantity of treated and untreated waste (in pounds), as well as the name(s) and RI Regulated Medical Waste Transporter Permit Number(s) of the transporter(s); (9) The signature of the applicant or a person duly authorized to act on behalf of the applicant; and (10) Any other information reasonably required by the Director to demonstrate that the applicant can safely generate and manage regulated medical waste in accordance with all applicable provisions of these regulations. 16Hospital, Laboratory, Clinic, Physician, Dentist, Veterinarian, Long-Term or Residential Health Care Facility, Blood Bank, Mortician, or Other (Specify type) -62- (c) Notification of Changes: A registered generator of regulated medical waste 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 after the effective date of the change(s). Notwithstanding the foregoing, The Director shall be notified, in writing, of any additional location(s) to be included on the registration before any regulated medical waste is generated at that location. (d) Expiration of Regulated Medical Waste Generator Registrations: Upon approval by the Director, a Regulated Medical Waste Generator Registration shall expire on 31 December of the year of issuance, unless sooner suspended or revoked. (e) Renewal of Regulated Medical Waste Generator Registrations (1) Requests for renewal of a Regulated Medical Waste Generator Registration shall be submitted not later than thirty (30) days prior to the expiration date of the current registration, and shall contain all the information required by Section 16.01(b) of these regulations without reference to any previously submitted material. (2) In any case in which a holder of a Regulated Medical Waste Generator Registration has filed an application in proper form for renewal not less than thirty (30) days prior to the expiration date of his/her existing registration, the existing Registration Number shall not expire until final action on the application has been taken by the Director. 16.02 REGISTRATION OF MORE THAN ONE GENERATOR AT THE SAME SITE (a) Any person who generates regulated medical waste at a location operated by a legal entity of which such person has no legal relationship must register as a generator of regulated medical waste as required by Chapter 23-19.12- 12 of the General Laws of Rhode Island, as amended, in the manner provided by Section 16.01 of these regulations. Such person shall be independently responsible for violations of the law and regulations that are committed by that person. (b) If two or more individual generators register in accordance with Section 16.01 as a single legal entity, they shall submit to the Director verification that they are a legal entity which is responsible for the actions of its agents regarding the generation and management of regulated medical waste. (c) Two or more individual generators at the same location who share examination rooms, jointly combine all regulated medical waste, and are each Small Quantity Generators, but are not a single legal entity, shall each be required to obtain separate registrations pursuant to Section 16.01 of these regulations. Each person shall be independently responsible for violations of the law and regulations that are committed. For the purpose of determining registration categories, each such individual generator shall -63- assume, unless proven other-wise, an equal proportion of all regulated medical waste generated at that location. 16.03 ANNUAL REGISTRATION FEE (a) The Director has established the following annual registration fees for generators of regulated medical waste: Generator Waste Generated Per Annual Fee For Category Generator Per Year Registration 1 Less than 25 lbs. $30 per generator 2 25 lbs. to 100 lbs. $40 per generator 3 101 lbs. to 500 lbs. $60 per generator 4 501 lbs. to 2,000 lbs. $160 per generator 5 More than 2,000 lbs. $200 per generator (b) Prorating of Fees. Any person submitting an application for a new Regulated Medical Waste Generator Registration between 1 July and 31 December shall pay one-half of the appropriate fee specified in Section 16.03(a) of these regulations. The fee for a new Regulated Medical Waste Generator Registration submitted between 1 January and 30 June shall not be prorated. (c) Adjustments to Fees. A facility that generates more regulated medical waste than permitted under their current Generator Category during the issuance period shall, upon renewal, be responsible for payment of the renewal registration fee for the higher Generator Category. No permit fee adjustments shall be made during the issuance period for facilities that generate less regulated medical waste than permitted under their current Generator Category. 17.00 LICENSES FOR STORAGE, TREATMENT AND/OR DESTRUCTION OF REGULATED MEDICAL WASTE 17.01 GENERAL REQUIREMENTS (a) No person or legal entity shall engage in the storage, treatment and/or destruction of regulated medical waste unless that person or entity shall have been issued a license by the Director for that purpose. (b) Notwithstanding the requirements of Section 17.01(a) of these regulations: (1) The owner and/or operator of a treatment, destruction, and/or disposal facility that is operating under a solid waste management facility license, issued pursuant to Rhode Island General Laws, Section 23-18.9-8 and the Rules and Regulations for Solid Waste Management Facilities, for the current license year during which these regulations take effect shall comply with this Section by the next license renewal date. -64- (2) The owner and/or operator of a solid waste management facility which has a solid waste management facility license, issued pursuant to Rhode Island General Laws, Section 23-18.9-8 and the Rules and Regulations for Solid Waste Management Facilities shall have an additional ninety (90) days beyond said expiration date to comply with the requirements of this Section if there is less than six (6) months time between the effective date of these regulations and the expiration of said license. (3) The owner and/or operator of a solid waste management facility which has applied for a solid waste management facility license pursuant to Rhode Island General Laws, Section 23-18.9-8 and the Rules and Regulations for Solid Waste Management Facilities but has not yet received a license for the current license year during which these regulations take effect shall have six (6) months from the effective date of these regulations to comply. (c) Notwithstanding the requirements of Section 17.01(a) of these regulations, the following activities do not constitute practices requiring licensure under this section: (1) Storage by a generator before regulated medical waste is treated and/or destroyed on-site, or offered for transport off-site; and (2) Treatment and/or destruction of regulated medical waste by the generator of that waste if the treatment and/or destruction: (i) is carried out at a generating facility owned and operated by the generator of the regulated medical waste; and (ii) does not include regulated medical waste generated by any other person or legal entity. (d) Upon approval by the Director, a license for the storage, treatment and/or destruction of regulated medical waste transporter shall expire three (3) years from the date of issuance, unless sooner modified, suspended or revoked. (e) The holder of a license for the storage, treatment and/or destruction of regulated medical waste shall notify the Director, in writing, of any changes in the information provided with the license application. Said notification shall be provided in advance whenever possible. In no case shall the notification be postmarked later than five (5) business days after the effective date of the change(s). (f) The requirements established by this section shall be in addition to, and not in lieu of any requirements established by the Director pursuant to Chapters 23-18.9 and 23-63 of the General Laws of Rhode Island, as amended, the Rules and Regulations for Solid Waste Management Facilities, or other rules and regulations promulgated pursuant to the authority conferred by these statutes. -65- 17.02 REGULATED MEDICAL WASTE STORAGE, TREATMENT AND/OR DESTRUCTION LICENSE FEES (a) Each application for a license to construct a facility for the storage, treatment and/or destruction of regulated medical waste, or application to renew a license to operate a facility for the storage, treatment and/or destruction of regulated medical waste, shall include a fee in accordance with the following schedule: Type of Facility Application Fee Renewal Fee Medical Waste Incinerator $20,000 $10,000 Treatment, Disinfection and/or Destruction Facility $15,000 $7,500 Storage/Transfer Station $10,000 $3,000 Mobile Operation(s) $15,000 $7,500 (b) Multiple Operations at One Facility: Facilities that perform multiple operations as part of a single facility operation shall only be required to possess the license with the highest fee category applicable to the activities performed at that site. However, two or more independently staffed facilities operating on the same site shall require a license for each independent facility, as well as the appropriate fee for each independent facility. (c) The fees established by this section shall be in addition to any fees assessed by the Director pursuant to Chapters 23-18.9 and 23-63 of the General Laws of Rhode Island, as amended, the Rules and Regulations for Solid Waste Management Facilities, or other rules and regulations promulgated pursuant to the authority conferred by these statutes. 18.00 VARIANCES 18.01 APPLICATION: An application for a variance from the segregation, handling, transportation, storage, or treatment requirements of the medical waste rules and regulations shall be made in writing to the Department. 18.02 REVIEW: The Director shall evaluate each request for a variance. Such variance may be granted provided the Director finds that such request will not be contrary to the purposes and policy expressed in Section 2.00 of these regulations and that the alternative methods proposed by the applicant fulfill the purposes of the rule from which the variance is requested. APPENDIX I GENERAL INSTRUCTIONS FOR COMPLETING THE MEDICAL WASTE TRACKING FORM The Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island require generators, transporters, intermediate handlers, and owners and operators of destination facilities (i.e. treatment, destruction or disposal facilities) to use this form for both inter- and intrastate transportation of regulated medical waste. Generators shall obtain the Medical Waste Tracking Form from: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 The Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island require generators, transporters, intermediate handlers, and destination facilities to complete the form according to the following instructions: MEDICAL WASTE TRACKING FORM SPECIFIC INSTRUCTIONS The generator completes Items 1-15, the transporter and/or intermediate handlers completes Items 16-21, and the owner or operator of the destination facility completes Items 22-23. The transporter may assist the generator in completing any of the items, but the generator is responsible for ensuring the accuracy of information entered on the form and shall sign Item 15 after Items 1-14 are completed. Item 1. Generator's Name and Mailing Address. Enter the name and mailing address of the generator. The mailing address shall be for the location where the generator's tracking forms will be handled for purposes of recordkeeping and exception reporting (e.g., the generator's billing office, corporate headquarters, or the actual site of generation). While the address entered here need not identify the particular site of generation, the generator shall maintain its records so that each shipment of regulated medical waste, as defined by a unique Tracking Form Number, can be associated with the actual sites of generations. Item 2. Tracking Form Number. This is the unique number that the generator must assign to each shipment of regulated medical waste. It will ensure that each individual shipment can be identified and independently tracked from the site of generation. Item 3. Telephone Number. Enter the telephone number for the generator representative who can provide additional information about the shipment in the event of an emergency, or in the event the transporter, intermediate handler or destination facility requires it for other reasons (e.g., to inform the generator that an alternative disposal facility must be used). Item 4. RI Regulated Medical Waste Generator Registration Number. This is the unique Registration Number assigned to a generator of Regulated Medical Waste pursuant to Section 16.00 of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island. A Generator is not permitted to ship regulated medical waste generated in Rhode Island without a current valid Regulated Medical Waste Generator Registration Number. Item 5. Transporter's Name and Mailing Address. Enter the name and address of the regulated medical waste transporter who will be the first transporter of the waste listed on the tracking form. The mailing address shall be the business mailing address of the transporter. Item 6. Telephone Number. Enter the telephone number of the transporter that the generator, intermediate handler or destination facility may call to obtain information regarding medical waste shipments. Item 7. RI Regulated Medical Waste Transporter Permit Number. Enter the RI Medical Waste Transporter Permit Number issued to the Transporter by the RI Department of Environmental Management. A Transporter is not permitted to carry regulated medical waste generated in Rhode Island without a current valid Regulated Medical Waste Transporter Permit. Item 8. Destination Facility Name and Address. The generator shall enter the name and site address of the off-site destination facility (i.e., treatment and destruction or disposal facility) that the generator has specified to receive the regulated medical waste. If the generator does not have this information, the transporter may complete this section, but only before the generator signs the form. Transfer facilities, other temporary storage facilities used by transporters for storage of waste during ordinary transport, and/or intermediate handlers used by the generator or transporter to either treat or destroy the waste (but not both) shall not be listed as the destination facility. Item 9. Telephone Number. Enter the destination facility's telephone number which a generator or transporter may call to obtain information regarding the status of a shipment. Item 10. State Permit or ID Number. This Item is only completed if the destination facility is located in Rhode Island. Otherwise enter "N/A". Item 11. Waste Description. All regulated medical waste shall be categorized as Regulated Medical Waste (Untreated) [Item 11(a)] or Regulated Medical Waste (Treated) [Item 11(b)]. Definitions of untreated and treated regulated medical waste are contained in Section 5.00 of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island. The generator shall determine the category of all regulated medical waste being offered for transport before completing Items 12 and 13. Item 12. Total Number Containers. Enter the total number of containers (e.g., bags, boxes, pails, drums, etc.) for each of the applicable waste categories in the corresponding space. An entry is required for each space. Enter "NONE" if necessary. Item 13. Total Weight. Enter the total weight of the waste by applicable waste category in the corresponding space. If the waste is oversized and is not packaged in a standard container, a volumetric measure may be used. However, the unit of measure shall be noted in that space as well. An entry is required for each space. Enter "NONE" if necessary. Item 14. Special Handling Instructions and Additional Information. Generators may use this space to indicate special transportation, treatment, storage, or disposal information or Bill of Lading information, including alternative treatment and/or disposal facility information, if necessary. Generators may also include in this box a written request for the destination facility to certify disposal of the regulated medical waste through signature and dating within this box. (Note: The signature in the Destination Facility Certification Item (Item 22) is only to be used to certify receipt of the waste at the time of delivery to the facility.) For international shipments, generators shall enter in this space the point of departure City and State for those wastes destined for treatment and destruction, or disposal outside the United States. This space may also be used if there is need to identify an intermediate handler and/or a third transporter. This space should also be used to provide special instructions or additional information regarding oversized regulated medical waste that cannot be easily packaged in plastic bags or standard containers. In these instances, enter a description of the waste including whether the waste is untreated or treated, the number of pieces, and the approximate total weight. Item 15. Generator's Certification. The generator must read, sign by hand, date this certification statement and enter the name of the generator into the certification statement. The person signing the statement must be authorized to make the required declarations, in writing, by the person in charge of the generator's operations. The generator must make certain that Items 1-14 are completed prior to signing the form. Item 16. Transporter 1 Certification of Receipt. The first transporter is required to acknowledge the acceptance of the waste shipment from the generator by signing the form in this space and recording the date of acceptance. Any discrepancies or other related information should be noted in the Discrepancy Item (Item 23) of the tracking form before signing it. In those instances when a transporter initiates a tracking form, he must complete Items 1-15 and must also certify receipt as transporter 1, if he is also the first transporter as identified in Item 5 (Transporter's Name and Mailing Address). Item 17. Transporter 2 or Intermediate Handler Name and Address. In the event the waste shipment is to be transported by a second transporter or is taken to an intermediate handler, the recipient must enter its name and business mailing address information in this place. Item 18. Telephone Number. Enter the telephone number of the second transporter or intermediate handler to be used when checking or investigating the status of a shipment. Item 19. Transporter 2 or Intermediate Handler RI Regulated Medical Waste Transporter Permit Number. If applicable, enter the RI Regulated Medical Waste Transporter Permit Number of the secondary transporter or intermediate handler. [See instructions for Item 7.] Item 20. Transporter 2 or Intermediate Handler Certification of Receipt. A secondary transporter or intermediate handler is required to certify acceptance of the waste shipment by printing or typing the name of the person accepting the waste, recording the date of acceptance, and signing the form. Any discrepancies or other related information shall be noted in the Discrepancy Item (Item 23) of the tracking form before signing this box. Item 21. New Tracking Form Number. If the regulated medical waste shipment is consolidated or reassigned to a new tracking form, the new tracking form number must be recorded in this box on the original generator's form. Item 22. Destination Facility. The authorized representative of the destination facility certifies receipt and acceptance of the shipment on behalf of the owner of the facility by completing this box. If no discrepancies are noted, the authorized representative should place a checkmark before the statement "received in accordance with Items 11, 12, and 13," print or type his name, record the date of acceptance, and sign the box. If there are any discrepancies he should not place a check there. He should, instead, note the discrepancies in Item 23. If for some reason the regulated medical waste was delivered to a facility other than that indicated in Item 8, then the authorized representative of the facility that accepted the waste completes Item 14 by entering the name, address, telephone number and the facility permit or identification number, if any, of the facility accepting the waste. Item 23. Discrepancy Item. The authorized representative of the destination (or alternate) facility, on behalf of the owner or operator, shall note any discrepancy between the waste described on the tracking form and the waste actually received at the facility. All discrepancies shall be noted by inclusion in Item 23. Owners and operators of facilities who cannot resolve discrepancies within fifteen (15) days of receiving a waste shipment shall file a discrepancy report, as required in Section 15.04 of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island. Discrepancy reports shall be submitted to: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 [Note: In some instances, due to the consolidation or remanifesting provisions of this part, transporters and intermediate handlers may also need to record discrepancies.] APPENDIX II GENERAL INSTRUCTIONS FOR COMPLETING THE ON-SITE MEDICAL WASTE INCINERATOR REPORT The Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island require generators who incinerate regulated medical waste on-site to submit an On-site Medical Waste Incineration Report for the periods January 1 to June 30 and July 1 to December 31 of each year. These reports are due 45 days after the end of the reporting period. Generators shall submit completed On-site Medical Waste Incineration Reports to: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 The Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island require generators to complete the report according to the following instructions: ON-SITE MEDICAL WASTE INCINERATION REPORT SPECIFIC INSTRUCTIONS The following describes each section of the On-Site Medical Waste Incineration Report and provides instructions for completing each of these sections (i.e., boxes). Boxes 1 through 5 require general information about the facility. Boxes 6 through 8 require specific information about the waste incinerated and technical information regarding the incinerators themselves. Box 9 requires the facility owner or operator to certify the accuracy of the information submitted. If there is more than one on-site incinerator used to incinerate regulated medical waste, complete Box 8(a) for the first incinerator and Box 8(b) for the second incinerator. Use additional sheets to provide the required incinerator information for a facility with more than two incinerators. The Certification statement (Box 9) shall be included on each additional sheet and shall also be signed by the owner or owner's authorized representative. Box 1. Reporting Period. Mark an "X" in the box that specifies the reporting period for the information you are submitting, and insert the appropriate year. Box 2. Facility Name and Mailing Address. Enter the name and mailing address of the incinerator facility. Box 3. Location of Incineration Facility. If the location address of the incineration facility is the same as the mailing address entered in Box 2, mark an "X" in the designated box. If the location address is different from the mailing address, enter the location information. Box 4. Type of Facility. Mark an "X" in the box that best describes the facility that owns or operates the incineration facility. If the categories do not accurately represent your facility, mark the "other" category and specify the facility type in the space provided. Box 5. Contact Person at the Facility. Enter the name, title, and telephone number of the person who is most knowledgeable about the incineration operations at your facility. Box 6. Waste Feed Information. This item pertains to the quantities of regulated medical waste incinerated at your facility. When entering a response, right justify the entry. A. Approximate Total Quantity of Regulated Medical Waste Incinerated. Enter the total weight (in pounds) of the regulated medical waste incinerated at your facility (total of all incinerator units) during the six month reporting period. To identify the quantities of regulated medical waste incinerated, refer to the operating logs kept for each incinerator at your facility as required under Section 12.02 of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island. B. Approximate Percentage of the Total Waste Incinerated that is Regulated Medical Waste. Using the information from your operating log, calculate the percentage (by weight) of the total waste incinerated that is regulated medical waste. To do this, divide the amount of regulated medical waste incinerated by the total amount of waste incinerated. Multiply the result by 100. Enter the number in the space provided. C. Approximate Quantity of Regulated Medical Waste Received from Sources Outside the Facility. Enter the total weight (in pounds) of regulated medical waste received from sources outside your facility during the six-month reporting period. An example of outside sources would include a facility that receives waste from a physician with an office several miles away. Box 7. Total Number of incinerators at this Facility. Enter the total number of incinerators that burn regulated medical waste at your facility. Box 8. Incinerator Design Information. To complete Items A through D in this box, refer to design blue prints, manufacturer's information, or other sources. A. Age of Unit. Enter the age of the incinerator unit in years. B. Type of Unit. Mark an "X" in the box that describes this incinerator type. - An "excess air" unit is usually a compact box-like structure with chambers and baffles, and it operates with high air flows to assure adequate combustion. It is usually loaded manually through a charging door. - A "starved air" unit is usually cylindrical, but can be rectangular, and it typically has combustion air fed through the floor or on the sides. The waste is usually manually loaded, although larger units can be mechanically loaded. - A "rotary kiln" unit is cylindrical and rotates about the lengthwise axis. If this incinerator is not described by any of the three groups listed, mark an "X" in the box labeled "other" and describe the unit in the space provided. If necessary, attach additional sheets. C. Number of Combustion Chambers. Mark an "X" in the box that describes the number of combustion chambers in this incinerator. D. Design Charging Capacity. Enter the maximum amount of waste that the incinerator is designed to burn, in pounds per hour. If you cannot locate any records, estimate the number of pounds per hour that this unit is designed to burn. (NOTE: When entering a quantitative response, such as, rates, weights or time, right justify the entry.) Box 9. Certification. After completing this form, the facility owner or an authorized representative must sign and date the certification and indicate his or her title/position. ON-SITE MEDICAL WASTE INCINERATION REPORT I. FACILITY INFORMATION 1. REPORTING PERIOD [ ] January 1, 20___ to June 30, 20___ [ ] July 1, 20___ to December 31, 20__ 2. FACILITY NAME AND MAILING ADDRESS 3. LOCATION OF INCINERATION FACILITY [ ] Address of location is the same as mailing address, OR: ________________________________ ____________________________________ Facility Name Facility Name ________________________________ ____________________________________ Mailing Address Mailing Address ________________________________ ____________________________________ City State Zip CodeCity State Zip Code 4. TYPE OF FACILITY [ ] Hospital [ ] Laboratory Facility [ ] Veterinary Clinic [ ] Private Practice or Clinic [ ] Funeral Home / Crematorium [ ] Other – Please specify _____________________ 5. CONTACT PERSON AT FACILITY Name Title Phone Number 6. WASTE FEED INFORMATION ** TOTAL FOR ALL INCINERATORS SPECIFIED IN BOX 7** A. Approximate Total Quantity of __/___/___/___/___/___/___/___/ Pounds / six month Regulated Medical Waste reporting period Incinerated: B. Approximate Percentage of __/___/___/ % Total Waste Incinerated that is Regulated Medical Waste: C. Approximate Quantity of __/___/___/___/___/___/___/___/ Pounds / six month Regulated Medical Waste reporting period Received from Sources Outside This Facility: II. INCINERATION INFORMATION 7. TOTAL NUMBER OF INCINERATORS THAT INCINERATE REGULATED MEDICAL WASTE AT THIS FACILITY: _____________ 8 a. INCINERATOR DESIGN INFORMATION 8 b. INCINERATOR DESIGN INFORMATION A. Age of Incinerator Unit: ________ years A. Age of Incinerator Unit: ________ years B. Type of Unit: B. Type of Unit: [ ] Excess Air [ ] Excess Air [ ] Starved Air [ ] Starved Air [ ] Rotary Kiln [ ] Rotary Kiln [ ] Other–Please Specify [ ] Other–Please Specify ______________________ ______________________ C. Number of Combustion Chambers: C. Number of Combustion Chambers: [ ] One Chamber [ ] One Chamber [ ] Two Chambers [ ] Two Chambers [ ] Three or more Chambers [ ] Three or more Chambers D. Design Charging Capacity: D. Design Charging Capacity: ___/___/___/___/___/___/___/___/ ___/___/___/___/___/___/___/___/ Pounds per hour Pounds per hour 9. CERTIFICATION I certify I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. Name and official title of owner or owner’s authorized representative. Printed Name Signature Title Date APPENDIX III GENERAL INSTRUCTIONS FOR COMPLETING THE MEDICAL WASTE TRANSPORTER REPORT Transporters who are required to obtain a Medical Waste Transporter Permit (pursuant to Section 14.03 of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island) are also required by Section 14.14 of these regulations to submit a Medical Waste Transporter Report for the periods January 1 to June 30 and July 1 to December 31 of each year. A Medical Waste Transporter Report shall only include information that can be obtained from the tracking forms and transporter logs that have certification receipt dates [Item 10] that fall within the reporting period. A Medical Waste Transporter Report shall be submitted even if the transporter did not transport any regulated medical waste in Rhode Island during a reporting period. These reports are due 45 days after the end of the reporting period. Transporters shall submit completed Medical Waste Transporter Reports to: Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 The Rules and Regulations Governing the Generation, Transportation, Storage, Treatment Management and Disposal of Regulated Medical Waste in Rhode Island require transporters to complete the report according to the following instructions: MEDICAL WASTE TRANSPORTER REPORT SPECIFIC INSTRUCTIONS Section I. Transporter Identification Information Item 1. Reporting Period. Mark an "X" in the box that specifies the reporting period for the information you are submitting and insert the appropriate year. Item 2. Transporter Name and Mailing Address. Enter the name and the mailing address of the transporter who is completing this report. Item 3. RI Regulated Medical Waste Transporter Permit Number. Enter the RI Medical Waste Transporter Permit Number issued to your company by the RI Department of Environmental Management. Item 4. Certification for Intermediate Transporter. A transporter who (1) solely accepts regulated medical waste from transporters who have, themselves, transported the waste, and (2) delivers such waste only to another transporter for further movement, is considered and "intermediate transporter". If you were an intermediate transporter during the reporting period marked in Item 1, mark an "X" in the box corresponding to "YES" and enter your signature after the box. If you were NOT an intermediate transporter during the reporting period marked in Item 1, mark an "X" in the box corresponding to "NO". Item 5. Contact Person. Enter the name, title, and telephone number of the person who is most knowledgeable about your transportation operations, or the person who is responsible for the information in this report. Item 6. Certification. After completing this form, the company owner or an authorized representative shall sign and date the certification and indicate his or her title or position. If your organization has no legal owner (e.g., a local government entity), the individual within your organization who is responsible for the information in this report shall sign and date the certification and indicate his or her position. If you checked "YES" in Item 4, you only need to complete Section I (Items 1-6) of the report. If you checked "NO" in Item 4 you must also complete Sections II, III, and IV of the report. Section II. Disposition Information Item 7. Total Quantity of Regulated Medical Waste by Category and Destination. Enter the total weight (in pounds) of both treated and untreated regulated medical waste that was transported to each type of facility during the reporting period. Include only regulated medical waste from generators located in Rhode Island. If your company did not pick up any regulated medical waste from generators located in Rhode Island, enter "0" in the box. Right justify each entry. Item 8. Total Number of Generators from whom Regulated Medical Waste was Accepted. Enter the total number of generators in Rhode Island from whom you accepted regulated medical waste for transport during the reporting period. Right justify each entry. If your company did not pick up any regulated medical waste directly from a generator, enter "0" in the box and skip to Section IV [Item 10]. Item 9. Identity of Generators. Complete Items 9A through 9C for each individual generator in Rhode Island from whom you accepted regulated medical waste during the reporting period. The total number of generators entered in Item 8 shall equal the total number of generators identified in Item 9. [ NOTE: This form only provides space for identification of four generators. If you accepted regulated medical waste from more than four generators located in Rhode island, copy this page as needed and provide the information on each generator.] A. Name and Location of Generator. Enter the Regulated Medical Waste Generator Registration Number, name and the address representing the physical location of the generator (i.e., the location at which the waste is picked up). B. Type of Generator. Enter the code that best describes the generator's facility. If the categories do not accurately represent a particular generator facility, Enter "10" and specify the generator facility type in the space provided. Code Generator Type 1 Hospital - includes waste generated in all hospital laboratories and departments. 2 Laboratory - includes clinical and research laboratories generating regulated medical waste. 3 Clinic - includes group-practice facilities that provide ambulatory care of one or more specialties such as hemodialysis, prenatal, or post partum care, surgical centers, family practice centers, etc. Also includes outpatient drug treatment facilities, and nonresidential medical day care facilities. 4 Physician - includes single and multiple private-practice physical offices. 5 Dentist - includes single and multiple private-practice dentist offices. 6 Veterinarian - includes single and multiple private-practice veterinarian offices. 7 Long Term or Residential Health Care Facility - includes facilities providing skilled or non-skilled care such as nursing homes and residential drug treatment centers. 8 Blood Banks - includes freestanding blood banks (not at a hospital) and their mobile off-site activities. 9 Embalmers/Funeral Homes - includes funeral homes and any other facilities where embalming procedures are conducted. 10 Other - includes any other facility generating regulated medical waste such as ambulance services, infirmaries, etc. If you enter this code, specify the type of generator in the space after the code. C. Quantity of Regulated Medical Waste Accepted from the Generator. For each category (untreated and treated), enter the amount of waste (in pounds) that you accepted from the generator during the reporting period. Right justify each entry. If you did not accept waste in one of the categories, enter "0" for that category. Section IV. Intermediate Handlers or Destination Facilities Identification Item 10. Total Number of Intermediate Handlers and Destination Facilities to which Regulated Medical Waste was Delivered. Enter the total number of intermediate handlers and destination facilities to which you delivered regulated medical waste during the reporting period. Right justify your entry. This box should include all facilities in Rhode Island as well in other states that accepted the regulated medical waste listed in Item 7. If you did not deliver any regulated medical waste to an intermediate handler or destination facility during the period enter "0" in Item 10 and do NOT complete the remainder of this section. Item 11. Identify of Intermediate Handlers and Destination Facilities. Complete Items 11A through 11C identifying each individual intermediate handler and destination facility to which you delivered regulated medical waste generated in Rhode Island. This form provides spaces for identification of four facilities. If you delivered waste to more than four facilities, copy this page as needed and provide the requested information for each facility. The number of facilities entered in Item 10 must equal the number of facilities identified in Item 11. A. Name and Location of Facility. Enter the name and the address representing the physical location of the facility. B. Type of Facility. Enter the code that best describes the intermediate handler and/or destination facility. Code Facility Type 1 Landfill. 2 Incinerator. 3 Treatment Facility (other than incinerator). 4 Destruction Facility (other than incinerator). 5 Treatment and Destruction Facility (other than incinerator). C. Quantity of Regulated Medical Waste Delivered to the Facility. For each category (untreated and treated) enter the quantity of waste (in pounds) that you accepted for transport to the intermediate handler or destination facility during the reporting period. Right justify each entry. If you do not deliver waste in one of the categories enter "0" for that category. MEDICAL WASTE TRANSPORTER REPORT I. TRANSPORTER IDENTIFICATION INFORMATION 1. REPORTING PERIOD [ ] January 1, 20___ to June 30, 20____ [ ] July 1, 20___ to December 31, 20____ 2. Transporter Name and Mailing Address 3. Regulated Medical Waste Transporter Permit Number ________________________________ __/___/___/___/___/___/___/___/ Facility Name ________________________________ 4. Certification for Intermediate Transporter Mailing Address [ ] Yes [ ] No ________________________________ ____________________________________ City State Zip CodeSignature 5. CONTACT PERSON AT FACILITY Name Title Phone Number 6. CERTIFICATION I certify I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. Name and official title of owner or owner’s authorized representative. Printed Name Signature Title Date II. DISPOSITION INFORMATION 7. Total Quantity of Regulated Medical Waste by Category and Destination Second Transporter or Intermediate Handler or Transfer Facility Destination Facility A. Untreated Waste __/___/___/___/___/___/___/lbs. __/___/___/___/___/___/___/lbs. B. Treated Waste __/___/___/___/___/___/___/lbs. __/___/___/___/___/___/___/lbs. III. GENERATOR IDENTIFICATION (USE ADDITIONAL SHEETS IF NECESSARY) 8. Total Number of Generators From Whom Regulated Medical Waste was Accepted: (If your answer is “0” skip to section IV) /___/,___/___/___,/___/___/___/ 9. Identity of Generators Please Complete Sections A, B, and C for each Generator A. Name and Location of Generator B. Type of Generator /___/___/ ________________________________ Refer to instructions for Code Facility Name If other, please specify: ___________________ ________________________________ C. Quantity of Regulated Medical Waste Mailing Address Accepted from Generator ________________________________ Untreated /___/___/___/___/___/___/___/lbs. City State Zip Code /___/___/___/___/___/___/ RI Regulated Treated /___/___/___/___/___/___/___/lbs. Medical Waste Generator ID Number A. Name and Location of Generator B. Type of Generator /___/___/ ________________________________ Refer to instructions for Code Facility Name If other, please specify: ___________________ ________________________________ C. Quantity of Regulated Medical Waste Mailing Address Accepted from Generator ________________________________ Untreated /___/___/___/___/___/___/___/lbs. City State Zip Code /___/___/___/___/___/___/ RI Regulated Treated /___/___/___/___/___/___/___/lbs. Medical Waste Generator ID Number A. Name and Location of Generator B. Type of Generator /___/___/ ________________________________ Refer to instructions for Code Facility Name If other, please specify: ___________________ ________________________________ C. Quantity of Regulated Medical Waste Mailing Address Accepted from Generator ________________________________ Untreated /___/___/___/___/___/___/___/lbs. City State Zip Code /___/___/___/___/___/___/ RI Regulated Treated /___/___/___/___/___/___/___/lbs. Medical Waste Generator ID Number IV. INTERMEDIATE HANDLER AND DESTINATION FACILITY (USE ADDITIONAL SHEETS IF NECESSARY) 10. Total Number of Intermediate Handlers and Destination Facilities to which Regulated Medical Waste was Delivered (If your answer is “0”, do not continue with this section) /___/___/___/ 11. Identity of Intermediate Handlers and Destination Facilities Please Complete Sections A, B, and C for each Facility A. Name and Location of Facility B. Type of Facility /___/___/ ________________________________ Refer to instructions for Code Facility Name If other, please specify: ___________________ ________________________________ C. Quantity of Regulated Medical Waste Mailing Address Delivered to the Facility ________________________________ Untreated /___/___/___/___/___/___/___/lbs. City State Zip Code Treated /___/___/___/___/___/___/___/lbs. A. Name and Location of Facility B. Type of Facility /___/___/ ________________________________ Refer to instructions for Code Facility Name If other, please specify: ___________________ ________________________________ C. Quantity of Regulated Medical Waste Mailing Address Delivered to the Facility ________________________________ Untreated /___/___/___/___/___/___/___/lbs. City State Zip Code Treated /___/___/___/___/___/___/___/lbs. A. Name and Location of Facility B. Type of Facility /___/___/ ________________________________ Refer to instructions for Code Facility Name If other, please specify: ___________________ ________________________________ C. Quantity of Regulated Medical Waste Mailing Address Delivered to the Facility ________________________________ Untreated /___/___/___/___/___/___/___/lbs. City State Zip Code Treated /___/___/___/___/___/___/___/lbs. APPENDIX IV LIST OF DISEASES ASSOCIATED WITH ISOLATION WASTES A. Biological waste and discarded materials contaminated with blood, excretion, exudates or secretions from humans who are isolated to protect others from certain highly communicable diseases. The following viral diseases are included in the list of "highly communicable diseases" associated with the class of Isolation Wastes. These diseases have been taken from Classification 4 of the Centers for Disease Control and Prevention/National Institutes of Health (CDC/NIH) document "Biosafety in Microbiological and Biomedical Laboratories, 3rd Edition" [May 1993]. INFECTIOUS AGENT DISEASE Congo-Crimean hemorrhagic fever virus Crimean hemorrhagic fever Junin virus Argentine hemorrhagic fever Machupo virus Bolivian hemorrhagic fever Lassa virus Lassa fever Marburg virus Marburg virus disease Ebola virus Ebola virus disease Absettarov virus Tick-borne encephalitis Hanzalova virus Tick-borne encephalitis Hypr virus Tick-borne encephalitis Kumlinge virus Tick-borne encephalitis Kyasanur forest disease virus Kyasanur forest disease Omsk hemorrhagic fever virus Omsk hemorrhagic fever Russian spring-summer encephalitis virus Russian spring-summer encephalitis Guanarito virus Any other Arboviruses, Arenaviruses, Filoviruses, Viruses or diseases identified as Biosafety Level 4 etiologic agents by the Centers for Disease Control and Prevention B. Isolated animals known to be infected with highly communicable diseases. The following diseases are included in the list of "highly communicable diseases" associated with animals. Unless otherwise noted by an asterisk (*), these diseases are part of the National Notifiable Disease Surveillance System list. Anthrax *Cat-Scratch Fever Disease Botulism *Ebola Virus Brucellosis *Ehrlichia canis Eastern Equine Encephalitis *Encephalomyocarditis Leptospirosis *Monkey B-Virus Lyme Disease *Monkey Marburg Virus Plague *Poxvirus Psittacosis (Chlamydiosis) *"Q" Fever Rabies *Rocky Mountain Spotted Fever Salmonellosis *Vesicular Stomatitis Trichinosis Tuberculosis Tularemia Appendix V State of Rhode Island Department of Environmental Management Office of Waste Management 235 Promenade Street Room 380 Providence, Rhode Island 02908-5767 (401) 222-2797 REGULATED MEDICAL WASTE TRANSPORTER PERMIT APPLICATION READ THE ENTIRE APPLICATION CAREFULLY !! Dear Medical Waste Transporter: Enclosed is your application to apply for/renew a permit to transport MEDICAL WASTE through and within the state of Rhode Island for the permit period ending June 30. Please complete and return these forms to the above address. Do not submit the application and attachments in a binder. Allow three (3) to eight (8) weeks for processing. If there are deficiencies in the application, the Department will contact you via written correspondence. You will be contacted when the application is approved, and should contact this office if you do not hear from us by the end of the 8 weeks processing period. Renewal applications for the new fiscal year are due April 1. INSPECTIONS The Department has implemented a COMPANY-CERTIFIED inspection program, thus eliminating the need for RIDEM staff inspections. Each company is required to list designated company inspectors who will perform inspections and attest to the accuracy of each inspection. A checklist for a unit inspection is attached. Please make copies of this form and submit one checklist for each unit you wish to permit. Each checklist submitted to this office must contain the signature of a designated inspector and these forms will be used as legal documents in the event of an enforcement action against the company. The Department will continue to perform random, unannounced vehicle inspections. Companies must maintain strict compliance with the requirements at all times. Units found to be deficient upon inspection are subject to administrative penalties. Upon approval of a company's application, decals will be issued for the specific units for which a checklist and a $100 per unit fee has been submitted. These decals are NOT TRANSFERRABLE and are to be placed on the driver's side of the permitted unit. SPILL MANAGEMENT PLANS All medical transporters are required to submit an emergency spill management plan in accordance with Rule 14.03 and 14.08 of the regulations. This spill management plan must be updated when any changes occur. This contingency plan must be on each vehicle at all times. FEES A fee of $100.00 (made payable to the General Treasurer State of Rhode Island) must be submitted to the Office of Management Services, per the attached remittal form, at the time the application is submitted. This will be credited to the cost of the first unit. You must submit $100 for each additional unit to be permitted. No decals will be issued until payment is received. Appendix V (Note: If the units are separate, the cost to permit one tractor is $100, and the trailer is an additional $100. These are two (2) units and two (2) checklists should be submitted.) APPLICATIONS MUST BE SENT TO THE OFFICE OF WASTE MANAGEMENT AND CHECKS MUST BE SENT TO THE OFFICE OF MANAGEMENT SERVICES IN ORDER TO APPROPRIATELY PROCESS YOUR APPLICATION. THE APPLICATION AND THE CHECK MUST BE MAILED SEPARATELY TO THE ADDRESSES LISTED IN THE APPLICATION. All additional fees must be accompanied by the Check Remittal Form included and submitted to the Office of Management Services when the inspection checklist is submitted to the Office of Waste Management. To improve the efficiency of the permitting process for both the Department and the regulated community, this year the Department will not require the submission of individual checklists for each vehicle for electronic filers. To be eligible to file electronically, the company must submit a Medical Waste Transporter Electronic Submittal Form, along with their application and accompanying data in the Department’s spreadsheet format only. The data may be sent on floppy disk or by e-mail. All correspondences should be addressed to Janice Angell at (401) 222-2797 (ext. 7517) e-mail jangell@dem.state.ri.us or Mark Dennen at (401) 222-2797 ext. 7112 e-mail mdennen@dem.state.ri.us or Tom Brandt at (401) 222-2797 ext. 7140 e-mail tbrandt@dem.state.ri.us. Appendix V RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT OFFICE OF WASTE MANAGEMENT 235 PROMENADE STREET PROVIDENCE RHODE ISLAND 02908-5767 (401) 222-2797 MEDICAL WASTE TRANSPORTER PERMIT APPLICATION PERMIT # RI - 1. COMPANY NAME MAILING ADDRESS CITY STATE ZIP PHONE ( ) LOCATION CITY STATE ZIP 2. OWNER 3. COMPANY EMERGENCY CONTACT PHONE ( ) FAX ( ) 4. COMPANY REGULATORY CONTACT PHONE ( ) FAX ( ) 5. INSURANCE COMPANY POLICY # EXPIRATION DATE 6. IS THIS IS A RENEWAL APPLICATION? YES NO If yes, have you made changes to: Designated Manifest Signer List? Yes No Contingency Plan? Yes No Training Plan? Yes No Business Concern Disclosure Statement? Yes No If yes to any above, you must submit the updated information with this application. 7. STORAGE OF PERMITTED VEHICLES: Appendix V MAILING ADDRESS CITY STATE ZIP 8. Location of Licensed Transfer Activities or Collection Points within Rhode Island (If applicable): MAILING ADDRESS CITY STATE ZIP PHONE ( ) 9. List all Destination Facilities used by your company for Medical Waste generated in Rhode Island (If applicable): Company Location Telephone # 10. Vehicle Information : Year Make V.I.N. # Last 5 digits Registration # State Type Capacity Appendix V 11. The following personnel are authorized by ______________ to sign the Medical waste Tracking Form: (Company Name) Name (Print or Type) Signature* * Designated employees must sign this form to signify their acceptance of this responsibility. Appendix V THIS APPLICATION MUST BE ACCOMPANIED BY THE FOLLOWING: An application fee of one hundred dollars ($100), must be submitted to the Office of Management Services, accompanied by the enclosed remittal form. The address for the Office of Management Services is located on the remittal form. The check must be made payable to the General Treasurer, State of Rhode Island. This application fee will be credited to one unit listed on the application. An additional one hundred dollars ($100) per unit will be required for each additional unit (a tractor is one unit a trailer is one unit). All fees must be accompanied by the remittal form and paid before a sticker is issued. An original (not photocopy or carbon copy) certificate of liability insurance issued in the name of the Office of Waste Management, Department of Environmental Management in the amount of at least one million dollars ($1,000,000.00). The company must submit for review and approval, a description of the procedures to be employed by the transporter, pursuant to Rule 14.03 and 14.08 of the Regulations, in response to spills or other emergency situations that could arise during transporting operations. Specific reference must be made to: 1) Type and location of emergency equipment on vehicles. 2) The drivers emergency response instructions including: i) Instructions to immediately notify the RIDEM at (401) 222-1360 (daytime) or (401) 222-2284 (24-hour). ii) The name and phone # of an emergency spill clean-up company. iii) Procedures for spill containment. iv) Copies of the "medical waste spill and accident report" (Appendix VI) to be completed within 48 hours of spill or accident. Appendix V Rhode Island Department of Environmental Management Office of Waste Management REMITTAL FORM * * * * ALL APPLICANTS PLEASE NOTE PROCEDURE * * * * The application fees and a copy of this completed page must be submitted to the Office of Management Services. The check must be made payable to the Rhode Island General Treasurer. Submit this form with the check attached to: RI Department of Environmental Management Office of Management Services 235 Promenade Street Providence, RI 02908-5767 ---------------------------------------------- The permit application form, and accompanying documents must be submitted to: RI Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 ----------------------------------------------- Please complete this page, attach it to the check or money order and submit to the Office of Management Services. This information must be provided to coordinate your fee with the application submitted. Applicant's Name: Address: CITY STATE ZIP Phone No.: ( ) Contact Person: _________ inspections x $100 per inspection = $____________(total amount submitted) TYPE OF PERMIT APPLICATION: ! NEW ! RENEWAL - PERMIT NO. RI____________________ FOR OFFICE USE ONLY: Fee Amount Received: $__________ Date Received: __________________ Received By: ____________________ Receipt Account: 17-18-211 Appendix V RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT OFFICE OF WASTE MANAGEMENT 235 PROMENADE STREET PROVIDENCE RHODE ISLAND 02908-5767 (401) 222-2797 Medical Waste Transporter Inspection Form ONE CHECKLIST MUST BE SUBMITTED FOR EACH UNIT (TRACTOR OR TRAILER) APPLICANT: _____________________________________ Date: ____________________________ RI Permit # RIMWTRANS: ___________________________ Fee Submitted: Yes / No Amount: _____________________ Check #: _________________________ Vehicle Type: Box _____ Other _____ Capacity _________ Reg. #: _______________ State: _____ Year/ Make: _______/_______________________________ Last 5 digits of V.I.N.: _______________ Vehicle Requirements 14.03(d) Spill Kit Cargo Body: ____ Required Absorbent Material _____ Fully Enclosed / Leak resistant ____ One gallon Disinfectant Sprayer _____ Good and Sanitary Condition ____ Appropriate Labels _____ Secure when unattended ____ Two (2) sets moisture resistant overalls, gloves, boots caps and tape. _____ Identification (name & number) in letters > 3” on ____ Eye protection both sides and back of cargo body ____ Respiratory protection _____ Required Biohazard / Medical Waste signage ____ Scoop, shovel, broom, bucket Management of Spills 14.08 ____ First Aid Kit _____ Management Plan on Vehicle meeting Requirements ____ Fire Extinguisher of Rule 14.08 ____ Lights, flares & other appropriate safety equipment ____ Communication Device In Accordance with Rhode Island General Law §23-19.1-18(h): I hereby certify that I am aware that any person who knowingly makes a false, statement, representation, or certification, in any application, record, report, plan, permit, or other document filed, maintained and used for the purpose of program compliance under this chapter shall be deemed guilty of a felony. _________________________________ ______________________________ _________ Signature of Designated Company Inspector Name (printed) Date Appendix V I , AM FAMILIAR WITH THE (Print name) MEDICAL WASTE TRANSPORTER PERMIT RULES AND REGULATIONS AND CERTIFY THAT ALL ENTRIES ON THIS APPLICATION ARE TRUE AND CORRECT. SIGNATURE DATE TITLE Appendix VI MEDICAL WASTE SPILL AND ACCIDENT REPORT This report form must be completed and submitted to the Department of Environmental Management within forty-eight (48) hours of a medical waste spill or an accident involving a vehicle transporting regulated medical waste if, as a result of the accident, regulated medical waste is no longer contained within the cargo-carrying body of the vehicle. I. Information Relating to the Transporter, Intermediate Handler, or Destination Facility 1. Company Name:____________________________________________________________ 2. Mailing Address:____________________________________________________________ CITY STATE ZIP 3. Company Owner:__________________________________________________________ 4. Contact Person on Matters Relating to Regulatory Compliance: Name: ___________________________________________________________________ Telephone Number: _______________________________________________________ 5. Contact Person for Emergencies: Name: ___________________________________________________________________ Telephone Number: _______________________________________________________ 6. RI Medical Waste Transporter Number (if applicable): _________________________________________________________________________ II Information Relating to the Spill or Accident 7. Date of the Spill/Accident: ___________________________________________________ 8. Time of the Spill/Accident: __________________________________________________ 9. Amount of Regulated Medical Waste Involved: _________________________________ 10. Location of the Spill/Accident: ______________________________________________ ____________________________________________________________________________ CITY STATE ZIP _________________ Appendix VI 11. Description of the Spill/Accident: __________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ 12. Description of Cleanup Efforts: _____________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ 13. Name and Address of Employees (and any other persons) involved in the Cleanup Effort: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ 14. Company Official Completing the Spill/Accident Report: Name (Please Print or Type): _____________________________________________________ Signature: __________________________________________________________________ Date: _______________________________________________________________________ _____________________________________________________________________________ Mail completed form to: Department of Environmental Management Office of Waste Management 235 Promenade Street Providence, RI 02908-5767 (401) 222-2797 Appendix VII BIOHAZARD Appendix VIII REGULATED MEDICAL WASTE SMALL-QUANTITY GENERATOR REPORT 1. Reporting Period [ ] January 1, 20 to June 30, 20 [ ] July 1, 20 to December 31, 20 2. Generator (Facility) Name and Mailing Address Name Address City State Zip Code 3. Generator Type [ ] 01 - Hospital [ ] 04 - Physician [ ] 07 - Long-term Care [ ] 02 - Laboratory [ ] 05 - Dentist [ ] 08 - Blood Bank [ ] 03 - Clinic/HMO [ ] 06 - Veterinarian [ ] 09 - Funeral Home [ ] 10 - Other 4. Regulated Medical Waste Generator ID Number: 5. Contact Person Name Title Telephone Number Appendix VIII p. 2 Small-Quantity Generator Report 6. Destination Site(s) How is waste transported to this site? (1) Name Address City State Zip Code How is waste transported to this site? (2) Name Address City State Zip Code 7. Quantity of Waste Transported Off-Site During Reporting Period Destination Site (1): Treated (lbs.) Untreated (lbs.) Destination Site (2): Treated (lbs.) Untreated (lbs.) Mail Completed report to: Department of Health Office of Environmental Health Risk Assessment 3 Capitol Hill Room 208 Cannon Building Providence, RI 02908-5067 Appendix IX STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS Department of Health Office of Environmental Health Risk Assessment 3 Capitol Hill, 208 Cannon Building Providence, RI 02908-5097 (401) 222-3424 INITIAL REGISTRATION OF REGULATED MEDICAL WASTE GENERATORS PLEASE TYPE OR PRINT CLEARLY. 1. Facility Information: A. Main Facility: Facility Name____________________________________________________________ Address__________________________________________________________________ City___________________________________State________Zip Code______________ Contact Person____________________________________Telephone_______________ B. Mailing address, if different from A above: _________________________________________________________________________ City___________________________________State________Zip Code_____________ C. Type of facility: please check appropriate box. If choosing the category "other", please specify. [ ] 01 - hospital; [ ] 02 - laboratory; [ ] 03 - clinic/HMO; [ ] 04 - physician; [ ] 05 - dentist; [ ] 06 - veterinarian; [ ] 07 - long-term care/nursing home; [ ] 08 - blood bank; [ ] 09 - embalmer/funeral home; [ ] 10 - other__________ D. [ ] If this is an application for a group practice, please check this box and list all practitioners' names below: ___________________________________ ________________________________ ___________________________________ ________________________________ E. [ ] If, according to the Rules and Regulations Governing the Management and Handling of Medical Waste in Rhode Island, you do not generate regulated medical waste, please check this box and go directly to Question 4 of the application (the signature block). Refer to the enclosed "Definitions" page for assistance. (OVER) Appendix IX 2. Regulated Medical Waste Information: A. Approximate total quantity of regulated medical waste generated at main facility, in pounds, in a 12 month reporting period:/ / / / / / / / B. Is regulated medical waste treated on-site? [ ] yes - continue with 2B [ ] no - go to 2C Method of treatment: [ ] autoclave; [ ] incineration; [ ] other thermal treatment (describe)_______________________________________________________ [ ] chemical treatment (describe)_______________________________________________________ [ ] other treatment (describe)_______________________________________________________ C. How is regulated medical waste transported off-site? [ ] Registered RI Medical Waste Transporter Transporter Name_______________________________________________________ Transporter Number_____________________________________________________ [ ] Generator/Employee Vehicle (may only be used if generating/shipping <50 pounds of regulated medical waste per month) Waste transported to: Name of facility___________________________________________________________ Address____________________________________________________________________ City____________________________________State___________Zip Code_________ Telephone Number________________________________________________________ 3. Satellite Facility Information: A. I/my organization generate(s) regulated medical waste at _________ satellite locations in RI. (If you generate RMW at facilities other than the facility indicated in Question 1A, please complete "Attachment A" for each satellite facility.) B. The approximate total quantity of regulated medical waste generated, in pounds, in a 12 month reporting period, for all facilities (main and all satellites) in RI is: / / / / / / / / 4. Signature I certify that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. _________________________________________________________________________________ Authorized Signature Title Date A T T A C H M E N T A Satellite Facilities Attachment A must be completed if you generate regulated medical waste at more than one site in Rhode Island. Please refer to the enclosed page entitled, "Regulated Medical Waste (RMW) - Determining Your Generator Status" for instructions. If you generate RMW at more than one satellite site, you may photocopy this page and complete for each site. A. Facility Name____________________________________________________________________ Address__________________________________________________________________ City___________________________________State________Zip Code______________ Telephone________________________________________________________________ B. Regulated Medical Waste Information: Approximate total quantity of regulated medical waste generated at this satellite facility, in pounds, in a 12 month reporting period: / / / / / / / / C. Is regulated medical waste treated on-site? [ ] yes - continue with C [ ] no - go to D Method of treatment: [ ] autoclave; [ ] incineration; [ ] other thermal treatment (describe)_______________________________________________________ [ ] chemical treatment (describe)_______________________________________________________ [ ] other treatment (describe)_______________________________________________________ D. How is regulated medical waste transported off-site? [ ] Registered RI Medical Waste Transporter Transporter Name_______________________________________________________ Transporter Number______________________________________________________ [ ] Generator/Employee Vehicle (may only be used if generating/shipping <50 pounds of regulated medical waste per month) Waste transported to: Name of facility___________________________________________________________ Address____________________________________________________________________ City____________________________________State_____________Zip Code________ Telephone Number________________________________________________________