250 R.I. Code R. 250-RICR-140-15-1.5

Current through October 15, 2024

Section 250-RICR-140-15-1.5 - Definitions

A. Wherever used in these regulations the following terms shall have the following meanings:

1. "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.

2. "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.

3. "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.

4. "Building" means any structure used or intended for supporting or sheltering any use or occupancy subject to these regulations.

5. "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.

6. "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.

7. "DEM" means the Rhode Island Department of Environmental Management.

8. "Department" means the Rhode Island Department of Environmental Management.

9. "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 and Organic Waste Management Facilities (Subchapter 05 Part 1 of this Chapter) if the facility is located within the State of Rhode Island.

10. "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. To be generally unrecognizable, all waste must be shredded such that the majority of waste is of a size of less than 1 inch and all sharps are ground to less than one half an inch.

11. "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 and Organic Waste Management Facilities (Subchapter 05 Part 1 of this Chapter) if the facility is located within the State of Rhode Island.

12. "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 Rhode Island Department of Environmental Management or from the Rhode Island Department of Health.

13. "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.

14. "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.

15. "Encapsulation" means the application of a substance that either creates a membrane over the surface and/or penetrates the material or binds its components together.

16. "EPA" means the United States Environmental Protection Agency.

17. "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.

18. "FIFRA" means the Federal Insecticide, Fungicide and Rodenticide Act.

19. "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.

20. "Hazardous waste" means any waste meeting the definition of a hazardous waste under DEM's Rules and Regulations for Hazardous Waste Management (Subchapter 10 Part 1 of this Chapter) that includes both those wastes defined under the Resource Conservation and Recovery Act as well as Rhode Island Wastes in DEM Rules and Regulations for Hazardous Waste Management (Subchapter 10 Part 1 of this Chapter).

21. "Health care professional" means any person required to be licensed by this state (or the state where he/she practices) to provide health care services, including, but not limited to, a physician, hospital, intermediate care facility or other health care facility, dentist, nurse, optometrist, emergency medical technician, podiatrist, physical therapist, psychiatric social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health services.

22. "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.

23. "Infectious agent" means any organism, such as a virus or a bacterium, that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans.

24. "Intermediate handler" means 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 Land Revitalization and Sustainable Materials Management, as per the Rhode Island Rules and Regulations for Solid Waste Management Facilities and Organic Waste Management Facilities (Subchapter 05 Part 1 of this Chapter).

25. "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.

26. "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.

27. "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. Such a tracking form may mean a paper form or its digital counterpart that is functionally equivalent to the form. Digital formats must be approved by the Department in writing prior to use. A medical waste tracking form must include the following fields:

a. A unique Tracking Form Number, Generator's Name and Mailing Address, RI medical waste generator registration number, and telephone Number

b. Transporter's Name and Mailing Address, Telephone Number and RI Regulated Medical Waste Transporter Permit Number

c. Destination Facility Name and Address, telephone Number, State Permit or ID Number

d. Waste Description, Total Number Containers, Total Quantity and unit of measure

e. Special Handling Instructions and Additional Information

f. Generator's Certification, transporter 1 Certification of Receipt, transporter 2 or Intermediate Handler Certification of Receipt, destination facility certification of receipt, New Tracking Form Number and destination facility (if applicable), and discrepancy item

28. "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.

29. "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.

30. "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.

31. "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.

32. "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.

33. "Regulated medical waste" means defined in § 1.2(C) of this Part.

34. "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.

35. "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.

36. "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.

37. "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.

38. "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.

39. "Storage" means the temporary holding of regulated medical wastes at a designated accumulation area before treatment, destruction, disposal, or transport to another location.

40. "Tracking form" means Medical Waste Tracking Form

41. "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 Land Revitalization and Sustainable Materials Management, as per the Rhode Island Rules and Regulations for Solid Waste Management Facilities and Organic Waste Management Facilities (Subchapter 05 Part 1 of this Chapter).

42. "Transportation" means the movement of regulated medical waste on a public way to any destination. However, movement on a public way entirely contiguous to the facility's property shall not be considered transportation.

43. "Transporter" means a person engaged in transportation of regulated medical waste.

44. "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.

45. "Treatment" means when used in the context of regulated medical waste management means any method, technique, or process designed to:

a. Completely and reliably inactivate Geobacillus stearothermophilus spores or Bacillus atrophaeus spores at a 4 Log₁₀ reduction or greater.

b. Technologies not based on thermal or chemical treatment must also demonstrate the ability to completely and reliably inactivate vegetative bacteria, fungi, viruses, parasites, and mycobacterium at a 6 Log₁₀ reduction or greater.

46. "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 and Organic Waste Management Facilities (Subchapter 05 Part 1 of this Chapter) if the facility is located within the State of Rhode Island.

47. "Universal biohazard symbol" means the biohazard marking conforming to 29 C.F.R. § 1910.1030(g)(1)(i).

48. "Untreated regulated medical waste" means regulated medical waste that has not been treated to substantially reduce or eliminate its potential for causing disease.

250 R.I. Code R. 250-RICR-140-15-1.5

Amended effective 4/22/2020