Rhode Island Code of Regulations › Title 250 - Department of Environmental Management › Chapter 140 - Waste and Materials Management › Subchapter 15 - Medical Waste › Part 1 - Medical Waste Regulations › Section 250-RICR-140-15-1.5 - Definitions

Current through June 14, 2024
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.