250-RICR-140-15-1
250-RICR-140-15-1. Medical Waste Regulations (version Amendment, 10/10/2010 to 11/20/2017)
STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS
DEPARTMENT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF WASTE MANAGEMENT
RULES AND REGULATIONS GOVERNING THE GENERATION,
TRANSPORTATION, STORAGE, TREATMENT, MANAGEMENT AND
DISPOSALOF REGULATED MEDICAL WASTE IN RHODE ISLAND
[Short Title: Medical Waste Regulations]
[Regulation DEM-OWM-MW-1-2009]
Promulgated pursuant to the authority conferred under Chapter 23-19.12 (Generation-
Transportation- Storage- Treatment- Management and Disposal of Regulated Medical Waste) of
the General Laws of Rhode Island.
MARCH 1992
AS AMENDED:
April, 1994
July, 2010
Page 2 of 66
Medical Waste Regulations, July 2010
TABLE OF CONTENTS
CONTENTS
PAGE
1.0
Authority............................................................................................................................ 4
2.0
Purpose, Scope, and Applicability................................................................................... 4
2.1
Purpose........................................................................................................................... 4
2.2
Scope and Applicability................................................................................................ 4
2.3
Regulated Medical Waste............................................................................................. 5
2.4
Regulated Medical Waste - Exclusions and Exemptions .......................................... 6
3.0
Enforcement and Inspections........................................................................................... 7
4.0
Effective Dates................................................................................................................... 8
5.0
Definitions.......................................................................................................................... 8
6.0
Identification and Segregation of Regulated Medical Wastes.................................... 12
6.1
Applicability ................................................................................................................ 12
6.2
Identification ............................................................................................................... 13
6.3
Segregation .................................................................................................................. 13
7.0
Packaging and Containment of Regulated Medical Wastes ....................................... 13
7.1
General Packaging and Containment Requirements.............................................. 13
7.2
Packaging Requirements for Sharps......................................................................... 14
7.2 Packaging Requirements for Fluids in Bulk Quantities............................................. 14
7.3 Packaging Requirements for Human Pathological Wastes ....................................... 15
7.5 Packaging and Containment Requirements for Other Regulated Medical Wastes 15
8.0
Storage of Regulated Medical Wastes........................................................................... 15
8.1
Applicability ................................................................................................................ 15
8.2
Exemptions .................................................................................................................. 16
8.3
General Storage Requirements.................................................................................. 16
9.0
Decontamination Standards for Reusable Containers................................................ 16
9.1
Applicability ................................................................................................................ 16
9.2
Standards..................................................................................................................... 17
10.0
On-Site Transport of Regulated Medical Wastes ........................................................ 17
11.0
Labeling and Marking Regulated Medical Waste for Off-Site Transport................ 18
11.1
Applicability ................................................................................................................ 18
11.2
Labeling Requirements .............................................................................................. 18
11.3
Marking (Identification) Requirements.................................................................... 18
12.0
On-Site Treatment and/or Destruction of Regulated Medical Waste........................ 19
12.1
Applicability ................................................................................................................ 19
12.2
Recordkeeping Requirements for On-Site Incineration ......................................... 19
12.3
Reporting Requirements for On-Site Incineration.................................................. 20
12.4
On-Site Steam Sterilization Standards ..................................................................... 20
12.5
Recordkeeping for Alternate On-Site Treatment and/or Destruction Methods... 22
13.0
Generator Requirements for Off-Site Transportation of Regulated Medical Waste23
13.1
Applicability ................................................................................................................ 23
13.2
General Requirements................................................................................................ 23
13.3
Use of the Tracking Form .......................................................................................... 26
13.4
Generators Exporting Regulated Medical Waste.................................................... 26
13.5
Recordkeeping............................................................................................................. 27
13.6
Exception/Discrepancy Reporting............................................................................. 28
Page 3 of 66
Medical Waste Regulations, July 2010
14.0
Transporter Requirements for Off-Site Transportation of Regulated Medical Waste
........................................................................................................................................... 30
14.1
Applicability ................................................................................................................ 30
14.2
Regulated Medical Waste Transporter Permit Requirements............................... 30
14.4
Use of the Medical Waste Tracking Form................................................................ 34
14.5
Marking (Identification)......................................................................................... 36
14.6
Delivery of Regulated Medical Waste....................................................................... 36
14.7
Management of Spills ................................................................................................. 36
14.8
Other Inspections and Department Actions............................................................. 38
14.9
Personnel/Equipment ................................................................................................. 38
14.10
Containerization of Regulated Medical Waste..................................................... 39
14.11
Temporary Storage................................................................................................. 39
14.12
Recordkeeping......................................................................................................... 39
14.13
Reporting ................................................................................................................. 40
15.0
Treatment, Destruction and Destination Facilities...................................................... 42
15.1
Applicability ................................................................................................................ 42
15.2
Requirements for Treatment, Destruction, and Destination Facilities.................. 42
15.3
Use of the Tracking Form .......................................................................................... 45
15.4
Tracking Form Discrepancies.................................................................................... 47
15.5
Recordkeeping............................................................................................................. 47
15.7
Treatment, Destruction, and Disposal of Regulated Medical Wastes.................... 48
16.0
Registration for Generators of Regulated Medical Waste.......................................... 50
16.1
General Requirements................................................................................................ 50
16.2
Registration of More Than One Generator at the Same Site ................................. 51
16.3
Annual Registration Fee............................................................................................. 51
17.0
Licenses for Storage, Treatment and/or Destruction of Regulated Medical Waste . 52
17.1 General Requirements.................................................................................................... 52
17.2
Regulated Medical Waste Storage, Treatment and/or Destruction License Fees. 53
18.0
Variances ......................................................................................................................... 53
18.1
Application................................................................................................................... 53
18.2
Review.......................................................................................................................... 54
19.0
Severability...................................................................................................................... 55
20.0
Superseded Rules and Regulations................................................................................ 55
APPENDIX I: Medical Waste Tracking Form ....................................................................... 56
APPENDIX II: On-Site Medical Waste Treatment Report.................................................... 61
APPENDIX III Medical Waste Trasporter Report................................................................ 62
APPENDIX IV: List of Animal Diseases Associated with Isolation Waste........................... 65
APPENDIX V: Highly Communicable Endemic Animal Diseases........................................ 66
Medical Waste Regulations 4 of 66
1.0
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 requirements and provisions of Chapter 42-17.1, “Department of Environmental
Management”, Chapter 42-17.6 “administrative Penalties for Environmental Violations” and
Chapter 23-19.12 of the General Laws of Rhode Island, as amended, in accordance with the
provisions of Chapter 42-35, “Administrative Procedures Act”, of the Rhode Island General Laws
of 1956, as amended.
2.0
Purpose, Scope, and Applicability
2.1
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.
2.2
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 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.
(e)
In certain situations involving outbreaks, or suspected outbreaks, of certain highly
communicable diseases (either human or animal) the Director, in consultation with the
Medical Waste Regulations 5 of 66
Rhode Island Department of Health as appropriate, may issue a written order requiring a
different standard of treatment for regulated medical waste associated with the outbreak.
(f)
The Terms and provisions of these Rules and Regulations shall be liberally construed to
permit the Department to effectuate the purposes of state law, goals and policies.
2.3
Regulated Medical Waste
Means a special category of solid waste (including solid, semisolid, or liquid materials) 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 2.4 of these regulations. Regulated medical waste shall also
include certain waste, as listed in this section that is generated in any process where it is likely to
have come in contact with human blood or body fluids. Regulated medical wastes mixed with
non-hazardous 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) Animal Pathological Waste: Contaminated animal carcasses, body parts, and bedding of
animals that were known to have either:
1) been exposed to infectious agents during research, including research in veterinary
hospitals, production of biologicals, or testing of pharmaceuticals or
2) been infected with highly communicable endemic diseases that are indicated in
Appendix V to require special handling of carcasses and other materials.
(c) Human Pathological Wastes: Tissues, organs, and body parts of humans that are removed
during surgery or autopsy, or other medical procedures (e.g., obstetrical procedures).
(d) Human Blood, Body Fluids and Blood Products
1) Liquid waste human bloods 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.
(e) Sharps: Objects 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
Medical Waste Regulations 6 of 66
these regulations, disposable syringes and needles are considered regulated medical waste
after one use. The following categories of wastes are considered sharps:
(1)
Medical and Veterinary 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,.
(2)
Unused Sharps: Unused, discarded hypodermic needles or other sharps as
described above with the exception that if the unused sharp is in its original
sealed packaging, it not by definition a RMW.
(3)
Other sharp Waste: This category of waste shall also include sharps used on
human beings or animals for other than medical procedures, such as sharps used
for cosmetic treatment, training purposes, circumcision or embalming
procedures.
(4)
Body Art Waste: any waste produced in the course of injecting or physically
altering a human being or animal including tattooing, ear piercing or any other
process where a foreign object is used to cut or pierce the skin. Waste generated
in this manner meeting the definition of sharps must be handled accordingly.
(f) Isolation Wastes: Biological waste and discarded materials contaminated with blood,
excretion, exudates, or secretions from isolated animals known to be infected with highly
communicable diseases. A list of these diseases may be found in Appendix IV. The Director
may update this list as new diseases are identified.
(g) Spill/Cleanup Material: Any material collected during or resulting from the cleanup of a
spill of regulated medical waste.
(h) Mixtures and Waste in Medical Waste Containers: Any waste which is a mixture of
regulated medical waste and some other type of waste that is neither radioactive nor a
hazardous waste of a type other than regulated medical waste shall be considered a regulated
medical waste. Also, any waste, when placed in a sharps container, bag with a biohazard
symbol, or other container labeled and/or designed for the packaging of regulated medical
waste, must be handled and treated as a regulated medical waste, even if the contents may not
have previously met the definitions in this section. If the waste is a radioactive and/or a
hazardous waste it must also be handled in accordance with Regulations appropriate for
radioactive and/or hazardous wastes.
(i) Crime Scene/Accident Cleanup Waste: any waste generated by commercial entities hired
to clean crime scenes or accidents that are saturated with human blood or are sharps or sharp
objects contaminated with human blood.
2.4
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
Medical Waste Regulations 7 of 66
(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)
This exemption 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.
(4)
Household medical waste, once it is accepted at a collection center shall become
Regulated Medical Waste, and the person responsible for the collection center
shall be regulated as a generator in accordance with the requirements of these
regulations. Similarly household medical waste shall become Regulated Medical
Waste when accepted by a Health Care Professional.
(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 2.4(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.
(g)
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.
(h)
Vaccination and Pharmaceutical Vials: Containers for commercially available vaccines
or other pharmaceuticals that do not have an attached needle, and that have not contacted
blood or body fluid.
3.0
Enforcement and Inspections
(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
Medical Waste Regulations 8 of 66
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.
4.0
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.
5.0
Definitions
Wherever used in these regulations the following terms shall have the following meanings:
"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,
Medical Waste Regulations 9 of 66
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. 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 on half
an inch.
"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.
"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.
"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.
Medical Waste Regulations 10 of 66
"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.
"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.
"Hazardous Waste" means any waste meeting the definition of a Hazardous Waste under DEM’s
Rules and Regulations for Hazardous Waste Management 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.
“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.
"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.
"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.
"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 Regulations 11 of 66
"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.
"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 2.3 of these regulations.
"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.
Medical Waste Regulations 12 of 66
"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 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.
"Transporter" means a person engaged in Transportation of regulated medical waste.
"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 Geobacillus stearothermophilus spores or Bacillus
atrophaeus spores at a 4 Log10 reduction or greater.
(2) 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; and
"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 BIOHAZARD marking conforming to 29 CFR
1910.1030(g)(1)(i)—
"Untreated regulated medical waste” means regulated medical waste that has not been treated to
substantially reduce or eliminate its potential for causing disease.
6.0
Identification and Segregation of Regulated Medical Wastes
6.1
Applicability
Medical Waste Regulations 13 of 66
(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 8.0 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 6.0 of these regulations. This training/ notification shall be
accomplished through the use of a medical waste procedure manual and/or through
appropriate training materials.
6.2
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.
(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.
6.3
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));
(3) Human Pathological wastes as defined in Section 2.3.
(4) Other regulated medical wastes.
(b)
Regulated medical wastes shall be placed in suitable containers, according to the
requirements of Section 7.0 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 6.0 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.
7.0
Packaging and Containment of Regulated Medical Wastes
7.1
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
Medical Waste Regulations 14 of 66
requirements for each category of regulated medical waste contained in Sections 7.2, 7.3 and 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:
(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 7.0 of these regulations. This training/ notification shall be accomplished through
the use of a medical waste procedure manual and/or through appropriate training materials.
7.2
Packaging Requirements for Sharps
(a)
In addition to the general packaging and containment requirements for regulated medical
wastes in Section 7.1 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.
(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 on the outside of the container.
7.3
Packaging Requirements for Fluids in Bulk Quantities
Medical Waste Regulations 15 of 66
In addition to the general packaging and containment requirements for regulated medical wastes in
Section 7.1 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 on the outside of the container.
7.4
Packaging Requirements for Human Pathological Wastes
In addition to the general packaging and containment requirements for regulated medical wastes
contained in Section 7.1, pathological wastes shall be placed in a container marked or labeled with the
words “Pathological Waste”, “Path Waste”, “Pathology Waste” or “Incinerate Only” or other labels
approved by the department on the lid or on the sides. Any waste placed in a container so marked must
be managed as pathological waste in accordance with the requirements of these regulations.
7.5
Packaging Requirements for Animal Pathological Waste
In addition to the general packaging and containment requirements for regulated medical wastes
contained in Section 7.1, Carcasses of animals contaminated with highly communicable endemic animal
diseases listed in Appendix V shall be handled in accordance with special handling instruction in
Appendix V.
7.6
Packaging and Containment Requirements for Other Regulated Medical Wastes
In addition to the general packaging and containment requirements for regulated medical wastes in
Section 7.1, those regulated medical wastes which are not sharps or fluids in bulk quantities, (including,
but not limited to, cultures and stocks, non-liquid pathological wastes, non-liquid animal wastes (where
the waste presents a risk of zoonotic disease), 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 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 shall be displayed on the container as well as on the bag.
8.0
Storage of Regulated Medical Wastes
8.1
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.
Medical Waste Regulations 16 of 66
(b)
Training/Notification Requirement: Generators shall notify in writing all employees
involved with the storage of regulated medical wastes of the provisions in Section 8.0 of
these regulations. This training/notification shall be accomplished through the use of a
medical waste procedure manual and/or through appropriate training materials.
8.2
Exemptions
Sharps containers, currently in use, are exempt from the generator storage requirements provided they
meet all the requirements in Sections 7.1 and 7.2 of these regulations;
8.3
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 non-putrescent state. Total storage
of regulated medical waste shall not exceed fifty (50) pounds or seven (7) calendar days,
whichever condition shall allow storage for the longer period of time. The seven day
storage period shall not include legal holidays and begins on the date the container was
filled or was no longer used for collection at the point of generation. Storage of Regulated
Medical Waste at a licensed Treatment, Storage and Disposal Facility shall be governed by
the applicable requirements for those facilities in these regulations and/or the facilities
permit conditions.
(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.
9.0
Decontamination Standards for Reusable Containers
9.1
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.
Medical Waste Regulations 17 of 66
(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 9.0 of these regulations. This training/notification shall be
accomplished through the use of a medical waste procedure manual and/or through
appropriate training materials.
9.2
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 appropriates both for the type of
container to be decontaminated and for the type of contamination present. The facility
or generator responsible for decontamination must submit sampling protocols and
results to demonstrate the technology, as installed, is providing adequate
decontamination.
(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 9.2(b) of these regulations, the container shall be managed (i.e.,
labeled and treated and/or disposed of) as regulated medical waste.
10.0
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 7.0 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)
The regulated medical waste shall not be subjected to violent mechanical stress during
on-site transport.
(d)
Wheeled carts shall be used for the transport of packages or containers of regulated
medical wastes if these packages or containers will be 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.
(e)
Any regulated medical waste that 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).
Medical Waste Regulations 18 of 66
(f)
Carts used for the transport of packages and containers of regulated medical wastes shall
be sturdy shall be constructed of finished materials that are impermeable to moisture and
capable of being easily maintained in a sanitary condition. Carts shall be routinely
cleaned and disinfected, and immediately cleaned and disinfected after use if the cart has
been contaminated by medical waste.
(g)
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.
(h)
The compaction of packages and containers of regulated medical wastes prior to or
during on-site transport is prohibited.
(i)
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 10.0
of these regulations. This training/notification shall be accomplished through the use of a
medical waste procedure manual and/or through appropriate training materials.
11.0
Labeling and Marking Regulated Medical Waste for Off-Site Transport
11.1
Applicability
(a)
All containers used for the packaging and containment of regulated medical wastes shall
be labeled with the universal biological hazard symbol 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 11.0 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 11.0 of these regulations. This training/notification shall be
accomplished through the use of a medical waste procedure manual and/or through
appropriate training materials.
11.2
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 include the words "Medical Waste",
or display the universal biohazard symbol. Red plastic bags used, as inner packaging need not display a
label.
11.3
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
or labeled with water-resistant paint/labels 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);
Medical Waste Regulations 19 of 66
(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.
12.0
On-Site Treatment and/or Destruction of Regulated Medical Waste
12.1
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 17.0 of these regulations, from:
Rhode Island Department of Environmental Management
Office of Waste Management
235 Promenade Street
Providence, RI 02908
(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 12.0 of these regulations. This training/notification shall be
accomplished through the use of a medical waste procedure manual and/or through
appropriate training materials.
12.2
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 12.2(a) of these
regulations from the effective date of these regulations;
Medical Waste Regulations 20 of 66
(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 13.2(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 the shipment;
(3) The total quantity and unit of measure 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.
12.3
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
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
12.3 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 year and from July 1 to December 31 of
each year. These reports are due forty-five (45) days after the end of the reporting period.
12.4
On-Site Steam Sterilization Standards
Medical Waste Regulations 21 of 66
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
Geobacillus stearothermophilus spores at a 4 Log10 reduction or greater. Testing must
demonstrate that inactivation is uniform and within containers reasonably likely to be
treated in the system.
(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
(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
(121oC) was reached during the sterilization process; or
(ii)
A temperature determined in accordance with Section 12.4(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 12.4(d)(1)(i), (ii) and/or (iii) above, said temperature shall be
maintained for a period of time sufficient to completely and reliably inactivate
Geobacillus stearothermophilus spores at a 4 Log10 reduction or greater.
Testing must demonstrate that inactivation is uniform and within containers
reasonably likely to be treated in the system.
(2) A record of this temperature shall be kept as explained in Section 12.4(g) of these
regulations.
(3) A steam sterilizer 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.
Medical Waste Regulations 22 of 66
(e)
Spore tests shall be conducted, at a minimum either once every forty (40) hours of
operation or weekly, whichever allows for a greater length of time between tests. These
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 Geobacillus
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 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;
(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 12.4(a) or (b) of these regulations were maintained.
(h)
The log required by Section 12.4(g) of these regulations shall be kept at least three (3)
years from the date the waste was treated.
12.5
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 15.7(e) of these regulations. Each generator shall maintain the
following records:
(a)
The approximate quantity and unit of measure of regulated medical waste that is subject to
the treatment and/or destruction process(es);
(b)
Approximate percent 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 13.2(b) and 13.2(d) of these regulations, information identifying the generator,
the date the waste was accepted, the quantity and unit of measure of waste accepted, and
the date the waste was treated and/or destroyed;
Medical Waste Regulations 23 of 66
(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 15.7(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.
13.0
Generator Requirements for Off-Site Transportation of Regulated Medical Waste
13.1
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 2.3 and 5.0 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 transport set forth in Sections 6.0, 7.0,
8.0, 9.0, and 11.0 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 12.0 of these regulations. In addition, generators
who treat and destroy regulated medical waste are subject to Sections 6.0, 7.0, 8.0, 9.0, and
10.0 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 13.0 of these regulations. This training/notification shall be accomplished through
the use of a medical waste procedure manual and/or through appropriate training materials.
13.2
General Requirements
Generator shall send regulated medical waste only to a permitted facility. Except as provided below,
he/she shall not offer regulated medical waste to a medical waste transporter that does not have a Medical
Waste Transporter Permit Number and a valid RI Medical Waste Transporter Permit as indicated by an
official sticker on each transportation unit. 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,
Medical Waste Regulations 24 of 66
(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 6.0, 7.0, 8.0, 9.0, 10.0, 11.0 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 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0 of these regulations and are exempt from:
(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 13.3 of these regulations;
(4) The exemption(s) contained in Sections 13.2(b)(1)-(b)(3) of these regulations shall
only be applicable if the following conditions are met:
(i)
The regulated medical waste is transported from the original generation point
to a satellite facility or central collection point owned by the generator.
(ii)
From the time the waste is received at the central collection point, the
generator must store and ship the waste in accordance with all other generator
requirements of these regulations, including requirements to use a medical
waste tracking form.
(A) Small Quantity Generators and Crime Scene Cleanup Contractors that
transport regulated medical waste between satellite facilities or to a
central collection point shall apply to the Department for a Letter of
Authorization. This authorization shall last for a period of three (3)
years, after which time the generator must reapply.
(B) Notwithstanding the requirements of Section 13.2(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 Letter of Authorization ;
provided that the appropriate logs are kept at both the original generation
point and the central collection point, as described in Section 13.5(b) of
these regulations; and
(C) Prior to utilization of a common storage facility pursuant to Section
13.2(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.
Notwithstanding 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
(D) Other than Small Quantity Generators may act as the manager/ agent for
agreements pursuant to Sections 13.2(b)(4)(i)(B) and (i)(C) of these
regulations provided that: they are located in the same building as the
Medical Waste Regulations 25 of 66
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
(iii)
The regulated medical waste is transported by the generator, or an authorized
employee, in a vehicle owned by the generator or authorized employee; and
(iv)
The generator shall compile a shipment log and maintain records as required
in Section 13.5(b) of these regulations.
(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 owned 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 Letter of Authorization from:
Rhode Island Department of Environmental Management
Office of Waste Management
235 Promenade Street
Providence, RI 02908;
(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 transporter permit and Letter of
Authorization as per Section 14 of these regulations from:
Rhode Island Department of Environmental Management
Office of Waste Management
235 Promenade Street
Providence, RI 02908;
(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 13.5 of these regulations.
(d)
Shipments of Sharps and Unused Sharps Through the U.S. Postal Service: Small
Quantity Generators who transport regulated medical waste (sharps and unused sharps) by
the U.S. Postal 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:
Medical Waste Regulations 26 of 66
(1) The package is sent by first class or priority mail in accordance with section 10.17
(Infectious Substances) of the United State Postal Service Domestic Mail Manual.
(2) The generator compiles a shipment log and maintains the original shipping papers as
required by Section 13.5 of these regulations;
(3) 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. These reports shall be received by the director
within forty-five (45) days of the end of each reporting period.
(d)
Transportation of sharps from residences by health care professionals: Health care
professionals and veterinarians who generate medical waste that would otherwise be
classified as household medical waste, may transport the waste back to their offices
without a medical waste tracking form, provided the waste is properly packaged in
accordance with per Section 7 of these Regulations and that the waste is properly handled
as Regulated Medical Waste upon arrival at the central collection point.
13.3
Use of the Tracking Form
(a)
Except as otherwise exempted in Section 13.2 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.
(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 copies.
(d)
The generator shall also:
(1) Sign the certification statement on the tracking form by hand;
(2) Obtain the signature of the initial transporter and include the date of acceptance on
the tracking form; and
(3) Retain one copy, in accordance with Section 13.5 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 13.3 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
(3) The last rail transporter to handle the waste in the United States if exported by rail.
13.4
Generators Exporting Regulated Medical Waste
Medical Waste Regulations 27 of 66
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 13.6 of these regulations.
13.5
Recordkeeping
(a)
Except as provided in Section 13.5(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 13.3 of these regulations, for at least three hundred and seventy five (375)
days from the date the waste was accepted by the initial transporter; and
(2) Retain for a period of three hundred and seventy five (375) days a copy of all
exception reports required to be submitted under Section 13.6 of these regulations.
(b)
Generators that are exempt from using the Medical Waste Tracking Form, as specified in
Section 13.2 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 hundred and seventy five (375) days from the date the waste was shipped. The
log shall contain the following information:
(i)
Date of shipment;
(ii)
Quantity and unit of measure 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 hundred and seventy five (375) days from the date that regulated medical waste
was accepted from each original generation point and shall contain the following
information:
(i)
Date of receipt;
(ii)
Quantity (and unit of measure) 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 13.2(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 hundred and
seventy five (375) days from the date of shipment that contains the following
information for each shipment or pickup:
Medical Waste Regulations 28 of 66
(i)
Transporter's name and address;
(ii)
Transporter's Regulated Medical Waste Transporter Permit number;
(iii)
Quantity and unit of measure 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 who transport their own regulated medical waste to a treatment,
destruction, or disposal facility as specified in Section 13.2(b)(4) of these regulations
shall compile and maintain a log for a period of three hundred and seventy five (375)
days 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 and unit of measure 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.
(3) Generators that transport regulated medical waste by the U.S. Postal Service 13.2(d)
of these regulations shall retain the original shipping papers and a shipment log for a
period of three hundred and seventy five (375) days from the date of shipment. The
log shall contain the following information:
(i)
Quantity and unit of measure 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.
13.6
Exception/Discrepancy Reporting
(a)
A generator that meets the conditions of Section 13.2(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
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
Medical Waste Regulations 29 of 66
(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) The generator shall keep a copy of the exception report for a period of at least three
hundred and seventy five (375) days 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 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) The generator shall keep a copy of this Discrepancy Report for a period of at least
three hundred and seventy five (375) days from the date of the report.
Medical Waste Regulations 30 of 66
14.0
Transporter Requirements for Off-Site Transportation of Regulated Medical Waste
14.1
Applicability
(a)
These requirements apply to persons who engage in transportation of regulated medical
waste in Rhode Island. No person or other legal entity shall engage in the transportation of
regulated medical waste on a public way in the State 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 14.2(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 13.2 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; and
(4) Wildlife rehabilitators authorized by DEM/ Division of Fish and Wildlife
transporting Regulated Medical Waste to a veterinarian that actively supervises their
activities.
(c)
A transporter of regulated medical waste shall also comply with Section 13.0 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 6.0, 7.0, 8.0, 9.0, and 11.0 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 16.0 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 Section 14.0 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 6.0, 7.0, 8.0, 9.0, 11.0 and 14.0 of
these regulations. This training/notification shall be accomplished through the use of a
medical waste procedure manual and/or through appropriate training materials.
14.2
Regulated Medical Waste Transporter Permit Requirements
(a)
Exemption: The requirements of this Section shall not be applicable to use of vehicles to
collect and transport regulated medical waste in emergency situations which present a
threat to public health and safety. In the event of an emergency, the Director shall be
immediately notified of each vehicle used for the cleanup and transportation of regulated
Medical Waste Regulations 31 of 66
medical waste. Notwithstanding this exemption, all collected regulated medical waste
shall be managed in accordance with all applicable regulations at all times subsequent to
this notification.
(b)
Contents of Application: A transporter shall submit an application for a Regulated
Medical Waste Transporter Permit on a form prescribed by the Director . Such application
shall include, as a minimum, the following:
(1) Name under which the application is being made;
(2) Applicant's business location(s) and mailing address if different from business
location(s);
(3) Applicant's business phone number;
(4) Name, address and phone number of the owner of the applicant company;
(5) The name(s), address(es) and phone number(s) of the applicant's personnel who can
be reached in case of an emergency;
(6) The name(s) and signature(s) of all company personnel who are authorized to sign
medical waste tracking forms;
(7) A list of all employees authorized to transport or otherwise handle Regulated Medical
Waste and a certification that these employees have been trained in the hazards of
blood borne pathogens. This list must be amended when new individuals are hired.
(8) The following information for each vehicle that may be used to transport regulated
medical waste:
(i)
The manufacturer;
(ii)
Model;
(iii)
Year of manufacture;
(iv)
Vehicle Identification Number (VIN);
(v)
Cargo-carrying capacity;
(vi)
Proof of ownership of each vehicle; and
(vii) Proof of current registration for each vehicle with the appropriate state motor
vehicle agency;
(9) The address of any transfer station(s) and/or vehicle parking area(s) used by the
applicant for storing or parking vehicles identified in Section 14.2(b)(7) of these
regulations;
(10) Location(s) to be used, pursuant to Section 14.11 of these regulations, for temporary
storage of regulated medical waste in vehicles;
(11) The specific location(s) and/or person(s) to which the transporter delivers or intends
to deliver regulated medical waste, and a signed notarized statement from each
person and/or location which certifies that said person/ location is in compliance with
all applicable licensing/permitting requirements for the jurisdiction(s) to which
regulated medical waste will be transported;
(12) A copy of the applicant's Spill Management Plan prepared in accordance with the
requirements of Section 14.7 of these regulations;
(13) The permit application fee specified by Section 14.2(f)(1) of these regulations;
(14) The signature of the applicant or a person duly authorized to act on behalf of the
applicant; and
(15) Any other information reasonably required by the Director to demonstrate that the
applicant can safely transport regulated medical waste and comply with all applicable
provisions of Section 14.0 of these regulations.
(c)
Notification of Changes: A transporter who has been issued a Regulated Medical Waste
Transporter Permit shall notify the Director, in writing, of any change(s) in the information
required by the permit application. Such notification shall be provided in advance
whenever possible. However, in no case shall the notification be postmarked later than
Medical Waste Regulations 32 of 66
five (5) business days after the effective date of the change(s). Notwithstanding the
foregoing, the Director shall be notified, in writing, of the name(s) and signature(s) of
additional company personnel authorized to sign medical waste tracking forms before the
employee(s) may sign the tracking forms.
(d)
Vehicle Requirements
(1) Vehicles used to transport regulated medical waste in Rhode Island shall, as a
minimum, meet the following requirements:
(i)
The vehicle shall have a fully enclosed, leak-resistant cargo-carrying body;
(ii)
The transporter shall maintain the cargo-carrying body in good sanitary
condition;
(iii)
The cargo-carrying body shall be secured if left unattended; and
(iv)
The regulated medical waste shall not be subject to mechanical stress or
compaction during loading and unloading or during transit;
(2) Vehicles used to transport regulated medical waste shall have the following
identification in letters no less than three (3) inches in height on both sides and the
back of the cargo-carrying body:
(i)
The name of the transporter;
(ii)
The transporter's Regulated Medical Waste Transporter Permit number; and
(iii)
A universal biohazard sign or the following words imprinted:
(A) MEDICAL WASTE; or
(B) REGULATED MEDICAL WASTE;
(3) A transporter shall not transport regulated medical waste in the same container with
other solid waste unless the transporter manages both as regulated medical waste in
compliance with these regulations; and
(4) The transporter shall not use the cargo-carrying compartment of the vehicle to
transport anything except regulated medical waste. Hazardous waste may be
transported with regulated medical waste if the following criteria are met:
(i)
The transporter vehicle is permitted to carry hazardous waste;
(ii)
The regulated medical waste and the hazardous waste are packaged separately;
(iii)
The hazardous waste is properly labeled, marked, packaged, and handled in
accordance with all applicable laws and regulations; and
(iv)
The transporter vehicle is identified, in accordance with all applicable
regulations, as carrying both regulated medical waste and hazardous waste.
(e)
Vehicle Inspection Requirements: Each vehicle identified in Section 14.2(d) of these
regulations shall be inspected by the applicant prior to application for a Medical Waste
Transporter Permit or application to add an additional vehicle to an existing permit. The
applicant must complete the Department’s vehicle checklist certifying the vehicle meets the
Department’s standards prior to the permitting of any vehicles. All equipment listed in the
checklist shall be kept on the vehicle at all times.
(f)
Regulated Medical Waste Transporter Permit Fees: Pursuant to Section 23-19.12-9 of
the General Laws of Rhode Island, as amended, the Director has established the following
fee schedule for Regulated Medical Waste Transporter Permits:
Medical Waste Regulations 33 of 66
(1) A permit application fee of one hundred dollars ($125) per vehicle identified on the
permit application;
(2) An annual registration fee of ($125) per vehicle, or a monthly fee of ($25) per vehicle
identified on the permit application or on subsequent amendments;
(3) No permit fee adjustments shall be made for vehicles that are removed from the
permit and not replaced.
(4) In the case of a tractor/trailer combination, the power unit (tractor) is the vehicle that
is required to have a permit. The non-powered unit (trailer) is not required to possess
a permit.
(g) Insurance: The holder of a Regulated Medical Waste Transporter Permit shall maintain
liability insurance sufficient to provide coverage of one million dollars ($1,000,000.00) per
incident involving the transport of regulated medical waste.
(h) Expiration of Regulated Medical Waste Transporter Permits: Upon approval by the
Director, a Regulated Medical Waste Company’s Registration shall expire three (3) years
from the date of issuance, unless sooner modified, suspended or revoked. However, the
transporter permits shall expire annually and the transporter must pay the annual registration
fee of $100 for each vehicle that carries waste.
(i)
Renewal of Regulated Medical Waste Transporter Permits
(1) Requests for renewal of a Regulated Medical Waste Transporter Permit shall contain
all the information required by Section 14.2 of these regulations without reference to
any previously submitted material.
(2) In any case in which a holder of a Regulated Medical Waste Transporter Permit has
filed an application in proper form for renewal not less than thirty (30) days prior to
expiration of his/her existing permit, the existing permit shall not expire until final
action on the application has been taken by the Director.
14.3
Accepting Regulated Medical Waste for Transport
(a)
Transporters shall not accept for transport within Rhode Island any regulated medical
waste unless the regulated medical waste is packaged in accordance with Section 7.0 of
these regulations and Labeled/Marked in accordance with Section 11.0 of these
regulations.
(b) Transporters shall not accept regulated medical waste for transport within Rhode Island
unless it is accompanied by a properly completed tracking form as required under Section
13.3 of these regulations unless the generator is exempt from the use of the tracking form
under Section 13.2 of these regulations.
(c)
Notwithstanding Section 14.3(b) of these regulations, a non-rail transporter may accept
from a rail transporter regulated medical waste that is not accompanied by a tracking form,
provided that such non-rail transporter:
(1) Signs and dates all copies of the medical waste tracking form which has been
forwarded by the generator or the first non-rail transporter to the accepting non-rail
Medical Waste Regulations 34 of 66
transporter, or, if the tracking form has not been received by the accepting non-rail
transporter, on the shipping paper;
(2) Leaves a copy of the signed and dated shipping paper with the rail transporter, if
applicable; and
(3) Retains a copy of the signed and dated shipping paper or tracking form, as applicable.
(d)
Before accepting regulated medical waste that is accompanied by a tracking form, a
transporter shall:
(1) Verify that the tracking form accurately reflects the number of containers and
quantity of all treated and untreated regulated medical waste accepted;
(2) On all copies of the tracking form, sign and indicate the date the waste was accepted
from the generator or prior transporter, as applicable; and
(3) If the transporter is the first transporter of the waste, return a copy of the signed and
dated tracking form to the generator before accepting the waste, or if the transporter
is a subsequent transporter of the waste, return a copy of the signed and dated
tracking form to the prior transporter before accepting the waste; and
(4) Return a signed copy of the tracking form to the generator before leaving the
generator's site.
(5) Retain one copy of the signed and dated tracking form.
14.4
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 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 accepted..
(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.
(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:
Medical Waste Regulations 35 of 66
(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 Re-manifesting Waste to a New Tracking Form
(1) A transporter may choose to consolidate or re-manifest to a single tracking form all
shipments of regulated medical waste transported in a single vehicle.
(3) When a transporter consolidates wastes on to a manifest, he/she shall:
(i)
Indicate on the original tracking form that the waste was reconsolidated with
the new tracking form number.
(ii)
Retain a copy of each tracking form in accordance with Section 14.12 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 consolidated tracking form initiated, a transporter shall maintain a
consolidation log indicating all shipments consolidated or re-manifested 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 quantity
and unit of measure) 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)
When a transporter receives from a treatment, destruction or destination facility a copy of a
tracking form which he initiated pursuant to Section 14.4(e) of these regulations, and
which the operator of such facility signed and dated in accordance with Section 14.4(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;
(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)
When a non-rail transporter accepts regulated medical waste from a rail transporter, such
non-rail transporter shall:
Medical Waste Regulations 36 of 66
(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.
14.5
Marking (Identification)
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;
(2) Transporter Regulated Medical Waste Transporter Permit number and;
(3) Date of receipt.
14.6
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 14.6(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 14.0 of these regulations, such transporter shall
immediately notify the Director of DEM.
14.7
Management of Spills
(a)
Spill Management Plan: All transporters, intermediate handlers, and destruction facilities
shall adopt and adhere to a written procedure developed by the transporter and approved
Medical Waste Regulations 37 of 66
by the Department, to govern the management and decontamination of regulated medical
waste spills.
(b)
Cleanup Equipment and Supplies: All transporters, intermediate handlers, and
destruction facilities shall have at each site, including each vehicle used to transport
regulated medical waste, appropriate equipment and supplies for cleaning up a spill of
regulated medical waste. Equipment and supplies shall include, but are not limited to, the
following:
(1) Spill Containment and Cleanup Kit: A spill containment and cleanup kit shall be
kept in each area utilized for the collection, transfer, storage, treatment, packaging or
other such handling of regulated medical wastes. All vehicles operating under a
Rhode Island Regulated Medical Waste Transporter Permit shall carry a spill
containment and cleanup kit in the vehicle whenever regulated medical waste is
transported. Personnel shall be trained in the use of the kit and the kit shall contain at
least the following items:
(i)
Absorbent material for spilled liquids. The absorbent material shall have a
rated capacity of one gallon of liquid for every cubic foot of regulated medical
waste that is normally managed in that area for which the kit is provided or ten
(10) gallons, whichever is less;
(ii)
One gallon of disinfectant in a sprayer capable of dispersing its charge in a
mist and in a stream. The disinfectant shall be of hospital grade and of a
formulation described in Section 14.7(c) of these regulations and be effective
against mycobacteria;
(iii)
Fifty (50) plastic infectious waste bags that meet the requirements of Section
7.5 of these regulations, accompanied by sealing tape (or devices for sealing),
and appropriate labels as required by Section 11.0 of these regulations. These
bags shall be large enough to overpack any box or other container normally
used for regulated medical waste handling by the facility;
(iv)
Two (2) sets of overalls, gloves, boots, caps and protective eye covering, all of
which shall be disposable and impermeable to liquids. Overalls, boots and
caps shall be oversized or fitted to medical waste handlers and be made of a
moisture resistant or moisture proof material. Gloves for handling regulated
medical waste where sharps are not present shall be durable and moisture
resistant or moisture proof. Gloves for handling sharps shall be puncture
resistant or puncture proof in addition to liquid resistant. Boots shall be of
durable moisture resistant or moisture proof material, which will not tear
under the stress of walking. At a minimum, protective-breathing devices shall
include surgical masks. The kit shall also contain tape for sealing wrists and
ankles;
(v)
Scoop shovels, push brooms, and buckets;
(vi)
A first-aid kit, fire extinguisher, lights, and other appropriate safety
equipment;
(vii) A suitable means of communication for summoning aid in an emergency; and
(viii) An approved copy of the Spill Management Plan as described in Section 14.7
of these regulations.
(c)
Disinfectants and Decontamination Procedures
(1) Approved routine decontamination procedures for soiled surfaces include, but are not
limited to:
Medical Waste Regulations 38 of 66
(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 14.7(a) of these regulations.
(e)
Reporting of Medical Waste Spills
(1) In the event of a spill of regulated medical waste by the transporter, the transporter
shall notify the Department immediately of the spill. In all cases of spills, the
transporter shall immediately take steps to contain and clean up the regulated medical
waste.
(2) In addition to the immediate notification requirement of Section 14.7(e)(1) of these
regulations, the transporter shall, within forty-eight (48) hours of a spill of regulated
medical waste, submit an accident report to the Director. A copy of the report shall
be kept on file for a minimum of three (3) years at the same location as the Regulated
Medical Waste Transporter Permit. The three (3) year period for retention shall start
from the date of report. Record retention periods shall be extended during the course
of any unresolved litigation, or when so requested by the Director or by EPA.
14.8
Other Inspections and Department Actions
Upon request of the Department, a medical waste transporter shall:
(a)
Permit the Department to inspect Tracking forms, shipment logs, reports, permits, licenses,
billing records, or other documents related to the transportation or other handling of
regulated medical waste.
(b)
Permit the Department to inspect any vehicle or related equipment or any vehicle parking
area used by the transporter involved in the handling, transporting, storing or transferring
regulated medical waste.
(c)
Decontaminate, utilizing procedures described in Section 14.7 of these regulations, or
permit the Department to decontaminate at the owner's expense, any vehicle or section of a
facility that has been in contact with regulated medical waste, or take or allow the
Department to take any other measures necessary to make such vehicle or facility safe.
14.9
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.
Medical Waste Regulations 39 of 66
14.10 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 6.0 and 7.0 of these
regulations.
14.11 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)
Regulated medical waste is stored in the vehicle for a period not to exceed one week, not
including legal holidays.
(d)
The regulated medical waste is stored in accordance with the provisions of Section 8.0 of
these regulations;
(e)
Such vehicle complies with the provisions of Section 14.2(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;
(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.
14.12 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 hundred and seventy five (375) days 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
Medical Waste Regulations 40 of 66
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 re-manifested 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 hundred and seventy five (375) days 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 hundred and seventy five (375)
days 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 14.13 of these regulations for
a period of three (3) years from the date of submission.
14.13 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 facility, intermediate handler, or transfer facility located
in Rhode Island. The reports shall be submitted in electronic format using the specifications in Appendix
III of these regulations.
(a)
[reserved]
(b)
One copy of the report described in Section 14.13(c) of these regulations shall be
submitted to:
Rhode Island Department of Environmental Management
Office of Waste Management
235 Promenade Street
Providence, Rhode Island 02908.
(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, addresses, and type of each generator from whom the transporter accepted
regulated medical waste;
(5) The amount, unit of measure and waste category (i.e., untreated or treated) of
regulated medical waste accepted from each generator;
(6) The total quantity 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;
Medical Waste Regulations 41 of 66
(7) The total 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;
(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.
(f)
Transporters shall submit the reports required in Section 14.13(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 13.6
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.
14.14 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 14.0 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 14.4 of these regulations.
Medical Waste Regulations 42 of 66
(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 signature of the next non-rail transporter on
the tracking form; and
(ii)
Retain a copy of the tracking form in accordance with Section 14.12 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.
15.0
Treatment, Destruction and Destination Facilities
15.1
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;
(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 15.2(a), 15.2(b), 15.3, 15.4 and 15.5
of these regulations.
15.2
Requirements for Treatment, Destruction, and Destination Facilities
(a)
A treatment, destruction, or destination facility shall not accept regulated medical waste
which is not packaged, labeled, and marked in accordance with Sections 7.0 and 11.0 of
these regulations.
Medical Waste Regulations 43 of 66
(b)
A treatment, destruction or destination facility shall not accept regulated medical waste
that is not accompanied by a tracking form that complies with Sections 13.0 and 14.0 of
these regulations.
(c)
No person shall operate a treatment, destruction, or destination facility at which regulated
medical waste is burned or otherwise treated and/or destroyed unless such treatment,
destruction, or destination facility complies with all applicable laws and regulations.
(d)
All treatment, destruction, or destination facilities shall keep a spill containment and
cleanup kit in or near any storage area, loading and unloading area, decontamination area,
and treatment area where regulated medical waste is managed. The location of the kits
shall provide for rapid and efficient cleanup of spills anywhere within these areas. The kit
shall consist of at least the following items:
(1) Absorbent material for spilled liquids. The absorbent material shall have a rated
capacity of one gallon of liquid for every cubic foot of regulated medical waste that is
normally managed in the area for which the kit is provided or ten (10) gallons,
whichever is less.
(2) One gallon of disinfectant in a sprayer capable of dispersing its charge in a mist and
in a stream. The disinfectant shall be of hospital grade and of a formulation
described in Section 14.7(c) of these regulations and be effective against
mycobacteria.
(3) Fifty (50) red plastic infectious waste bags that meet the requirements of Section
7.5(c) of these regulations, accompanied by sealing tape (or devices), and appropriate
labels as required by section 11.0 of these regulations. These bags shall be large
enough to overpack any box or other container normally used for regulated medical
waste handling by the facility.
(4) Two (2) sets of overalls, gloves, boots, caps and protective eye covering, all of which
shall be disposable and be impermeable to liquids. Overalls, boots and caps shall be
oversized or fitted to medical wastes workers and be made of a moisture resistant or
moisture proof material. Gloves for handling regulated medical waste where sharps
are not present shall be durable and of moisture resistant or moisture proof material.
Gloves for handling sharps shall be puncture resistant or puncture proof in addition to
liquid resistant. Boots shall be of durable moisture resistant or moisture proof
material which will not tear under the stress of walking. Minimum protective
breathing devices shall be surgical masks. Tape for sealing wrists and ankles shall
also be provided in the kit.
(5) A first aid kit (unless emergency medical care is available on the premises), fire
extinguisher, and other appropriate safety equipment.
(e)
The disinfectants used in cleaning up a spill shall be registered with the U.S. EPA as
hospital disinfectants that are also tuberculocidal, fungicidal, virucidal and effective
against HIV-1. Also approved as a disinfectant is one-to-ten (1:10) dilution of five percent
(5%) sodium hypochlorite solution.
(f)
All regulated medical waste treatment, destruction, or destination facilities shall, at a
minimum, implement the following procedures subsequent to a spill of regulated medical
waste upon its discovery:
Medical Waste Regulations 44 of 66
(1) The cleanup crew shall utilize the protective equipment described in Section 14.7 of
these regulations during the spill cleanup operation;
(2) Limit access to the spill area only to authorized personnel;
(3) Place broken containers and spillage inside overpack bags in the kit.
(4) Disinfect the area and take other cleanup steps deemed necessary. Any absorbent
materials used to disinfect the area shall be considered regulated medical waste;
(5) Clean and disinfect non-disposable items;
(6) Remove protective equipment and manage disposal items as regulated medical waste;
(7) Take necessary steps to replenish containment and cleanup kit;
(8) Call for emergency assistance if necessary;
(9) Report to the Director immediately all regulated medical waste spills or accidents,
unless the quantity of such spills is less than one cubic foot of waste.
(10) Submit a medical waste spill report to the Director within forty-eight hours, using the
spill or accident report form prescribed by the Director. Any regulated medical waste
spill outside the limited access areas shall be reported to the Director. A copy of the
report shall be on file at the treatment facility for a minimum of three (3) years. The
report form shall include, but not be limited to:
(i)
Name of facility;
(ii)
Name of employee(s) involved;
(iii)
Address of facility;
(iv)
Date of spill or accident;
(v)
Date of report;
(vi)
Short detailed summary of events; and
(vii) Procedure(s) used to clean the spill or accident.
(11) All spills shall be recorded in a log that is maintained for a minimum of three (3)
years from the date of the last entry in the log.
(g)
Treatment, destruction, and destination facilities shall:
(1) Store regulated medical waste in a manner and location that maintains the integrity of
the packaging;
(2) Maintain regulated medical wastes in a non-putrescent state, using refrigeration or
freezing when necessary;
(3) Lock outside storage areas containing regulated medical wastes to prevent
unauthorized access;
(4) Designate and label regulated medical waste storage areas not limited to authorized
personnel by posting a sign stating "Warning: Regulated Medical Waste" and/or
displaying the international biohazard symbol at all points of access; and
(5) Store regulated medical waste in a manner and location that is not accessible to
animals and does not provide a breeding place or a food source for insects or rodents.
(h)
Treatment, destruction and destination facilities shall adhere to the following storage
regulations:
(1) No regulated medical waste shall be stored more than fourteen (14) days;
Medical Waste Regulations 45 of 66
(2) No facility shall store more than seven (7) times its total maximum daily capacity for
treatment and/or destruction of regulated medical waste.
(3) All facilities shall formulate a plan and submit a copy to the Director for approval.
At a minimum the plan shall:
(i)
Address compliance with the requirements set forth in Section 15.2 (d), (f),
(g,) (h), of these regulations, and shall provide for the removal of regulated
medical waste to an alternate facility in the event that the facility is not in
compliance with Section 15.2 (h)(1) and/or (2) of these regulations;
(ii)
Be maintained at the treatment facility; and
(iii)
Designate an emergency coordinator and an alternate emergency coordinator.
(4) The facility shall implement the appropriate section(s) of its plan under the following
conditions:
(i)
Its maximum storage capacity for regulated medical waste (as determined by
Section 15.2(h)(2) of these regulations) has been exceeded; or
(ii)
The storage time for regulated medical waste has exceeded fourteen (14) days;
or
(iii)
The facility operator anticipates exceeding the maximum storage capacity
and/or the fourteen-(14) day storage time limit for regulated medical waste.
(5) A generator that also treats or destroys regulated medical waste generated on
premises owned or operated by the generator shall be subject to the requirements of
Section 15.2(h) of these regulations when the untreated regulated medical waste is
stored in a centralized storage area prior to treatment or destruction.
(i)
Training/Notification Requirement: The owner of a treatment, destruction or destination
facility shall notify in writing all employees involved with the treatment and destruction of
regulated medical wastes of the provisions in Section 15.0 of these regulations. This
training/notification shall be accomplished through the use of a medical waste procedure
manual and/or through appropriate training materials.
15.3
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 15.4 of these regulations on the tracking
form;
(3) Immediately give the transporter at least one copy of the signed tracking form;
(4) Retain a copy of each tracking form in accordance with Section 15.5(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:
Medical Waste Regulations 46 of 66
(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 6.0
through 13.8 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 13.3 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 14.12 of these regulations.
(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 15.4 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
Medical Waste Regulations 47 of 66
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 15.5
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 hundred and
seventy five (375) days from the date of acceptance of the regulated medical waste.
15.4
Tracking Form Discrepancies
(a)
Tracking form discrepancies required for:
(1) Any variation in piece count such as a discrepancy of one box, pail, or drum in a
truckload; or
(2) 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
(3) 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%).
(4) 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;
(5) For packaging that is broken, torn, or leaking; and
(6) 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 15.4(a)(4) of these regulations, the report shall specify the
quantity of waste received, the transporter, and the generator(s).
15.5
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:
Medical Waste Regulations 48 of 66
(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 13.2(b) of these regulations, and the
generator's address; and
(3) Copies of all discrepancy reports required by Section 15.4 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 13.2 (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.
15.7
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.
(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 approval from the local sewer authority, 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
Medical Waste Regulations 49 of 66
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 Isolation
Wastes : Acceptable technologies include:
(i)
Incineration
(ii)
In response to the threat posed by certain isolation waste (human or animal)
the Director may prescribe alternate treatment standards as described in Section 2.2
of these regulations.
(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.
(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 Geobacillus stearothermophilus spores or
Bacillus atrophaeus spores at a 4 Log10 reduction or greater; and
(ii)
Completely and reliably inactivate vegetative bacteria, fungi, viruses,
parasites, and mycobacteria at a 6 Log10 reduction or greater [this requirement
is applicable to technologies not based on thermal and chemical treatment];
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 end product of the
alternative technology does not exceed the total weight and/or volume of the
regulated medical waste prior to treatment and/or destruction. Testing must
also demonstrate that inactivation is uniformly and within containers
reasonably likely to be treated in the system.
Medical Waste Regulations 50 of 66
(2) Notwithstanding the provisions of Paragraph 15.7(e)(1) of these regulations, the
Director may deny any application for just cause within the scope and intent of these
regulations.
16.0
Registration for Generators of Regulated Medical Waste
16.1
General Requirements
(a)
As of January 1, 2012, no person whose primary business activity of purpose is the
diagnosis (including testing and laboratory analysis), treatment, 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 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 16.1(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 in a manner prescribed by the Director. The
Department may require this form to be filled out on paper or in an online format. 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 type 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 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, 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.
(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.
Medical Waste Regulations 51 of 66
(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 16.1(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.
16.2
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 16.1 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 16.1 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 16.1 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 assume, unless proven
otherwise, an equal proportion of all regulated medical waste generated at that location.
16.3
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
Medical Waste Regulations 52 of 66
(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 16.3(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.
17.0
Licenses for Storage, Treatment and/or Destruction of Regulated Medical Waste
17.1 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 17.1(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.
(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 17.1(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:
Medical Waste Regulations 53 of 66
(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 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.
17.2
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.
18.0
Variances
18.1 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.
Medical Waste Regulations 54 of 66
18.2
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 2.0 of these regulations and that the alternative methods proposed by the applicant fulfill
the purposes of the rule from which the variance is requested
Medical Waste Regulations 55 of 66
19.0
SEVERABILITY
If any provision of these Rules and Regulations, or the application thereof to any person or
circumstance, is held invalid by a court of competent jurisdiction, the validity of the remainder of
the Rules and Regulations shall not be affected thereby.
20.0
SUPERSEDED RULES AND REGULATIONS
On the effective date of these Rules and Regulations, all previous Rules and Regulations, and any
policies regarding the administration and enforcement of the Generation- Transportation- Storage-
Treatment- Management and Disposal of Regulated Medical Waste shall be superseded.
However, any enforcement action taken by, or application submitted to, the Department prior to
the effective date of these Rules and Regulations shall be governed by the Rules and Regulations
in effect at the time the enforcement action was taken or the application filed.
21.0
EFFECTIVE DATE
The foregoing Medical Waste Regulations, including all subsequent amendments as indicated on the title
page, after due notice and hearing, are hereby adopted and filed with the Secretary of State this ____ day
of ____________, 2010, to become effective twenty (20) days after filing, in accordance with the
provisions of the General Laws of Rhode Island, 1956, as amended, Chapter 42-35, specifically §§ 42-35-
3(a) and 42-35-4(b); Chapter 23-19.12.
_______________________________
W. Michael Sullivan, Director
Department of Environmental Management
Notice given on:
11/25/2009
Public Hearing held on:
1/14/2010
Filing Date:
__________
Effective Date:
__________
HWREG014/CS
.
APPENDIX I MEDICAL WASTE TRACKING FORM
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. The generator shall use a form that includes the
fields described below.
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 complete Items 16-21, and the owner or operator of the destination
facility complete 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 16.0 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.
Medical Waste Regulations 56 of 66
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 5.0 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 Quantity and units. Enter the total quantity 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.
Medical Waste Regulations 57 of 66
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 quantity.
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 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 18. 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 19. 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.
Medical Waste Regulations 58 of 66
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 20. 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 15.4 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
[Note: In some instances, due to the consolidation or re-manifesting provisions of this part, transporters and intermediate handlers may also need to record
discrepancies.]
Medical Waste Regulations 59 of 66
Medical Waste Regulations 60 of 66
1. Generator Name and Mailing Address
2. Tracking Form Number
3. Telephone Number ( )
4. RI Generator Reg. No.
5. Transporter’s name and Mailing Address:
6. Telephone Number ( )
7. RI Transporter Permit # RI- ____
8. Destination Facility Name and Address
9. Telephone Number ( )
10. State Permit or ID #
11. Waste Description
12. Total Containers
Total Weight
a. Reg. Medical Waste (untreated)
b. Regulated Medical Waste (treated)
14. Special Handling Instruction and Additional Information
GENERATOR
15. Generator’s Certification
Under penalty of civil or administrative action for the making or certification of false statements,
representation, or omissions, I declare on behalf of the generator ____________ that the contents of this
consignment are fully and accurately described above and are classified, packaged, marked and labeled in
accordance with all applicable state and Federal laws and regulations, and that I have been authorized, in
writing, to make such declarations by the person in charge of the generator’s operation.
_______________________________
_____________________________ _______________
Printed/ Typed Name
Signature
Date
INSTRUCTIONS FOR COMPLETING MEDICAL WASTE TRACKING
FORM
COPY 1- GENERATOR COPY: Mailed by Destination Facility to Generator
COPY 2- DESTINATION FACILITY COPY: Retained by Dest. Facility
Copy 3- Transporter Copy: Retained by Transporter
Copy 4- Generator Copy: Retained by Generator
As required under RIDEM Rules and Regulations for Medical Waste:
1.
This multi-copy (4 page) shipping document must accompany each shipment
of regulated medical waste being transported within Rhode Island.
2.
Item numbers 1-14 must be completed before the generator can sign the
certification. Item 22 must be completed by destination facility:
16. Transporter 1 (certification of receipt of regulated medical waste as
described in items 11,12 & 13).
____________________________ _______________ _________
Printed/typed Name
Signature
Date
17. Transporter 2 (certification of receipt of regulated medical waste as
described in items 11,12 & 13).
____________________________ _______________ _________
Printed/typed Name
Signature
Date
18. New Tracking Form # (for consolidated or re-manifested waste)
19. Destination Facility (certification of receipt of regulated medical waste
as described in items 11,12 & 13).
____________________________ _______________
_________
Printed/typed Name
Signature
Date
INSTRUCTIONS
TRANSPORTER
Destination
20. Discrepancy Box (Any discrepancies should be noted by items # and
initials).
MEDICAL WASTE TRACKING FORM RHODE ISLAND DEPT OF ENVIRONMENTAL MANAGEMENT
OFFICE OF WASTE MANAGEMENT
235 PROMENADE ST, PROVIDENCE, RI 02908-5767
Telephone: (401) 222-2797
Medical Waste Regulations 61 of 66
APPENDIX II: ON-SITE MEDICAL WASTE TREATMENT REPORT
Completed report should be sent to :
Rhode Island Department of Environmental Management
Office of Waste Management
235 Promenade St.
Providence, RI 02908-5767
1. REPORTING PERIOD (select one):
January 1, 20___ to June 30, 20___
July 1, 20____ to June 30, 20____
2. FACILITY INFORMATION
Facility Name: _____________________________________
Facility Mailing Address: ______________________________
City: _____________________ State: _____ Zip: ___________
Facility Physical Location: Same as Mailing Address or:
Street Address: _________________________________________
City: _____________________________________
3. TREATMENT INFORMATION
Type of Treatment (select one):
Incineration Autoclave
Electro-Thermal Deactivation
Other: _______________
Quantity of Waste Treated: ____________________ Units: lbs gal tons kg liters
4. CERTIFICATION
I am familiar with the operation described above and hereby certify that the information supplied above is
accurate and complete to the best of my knowledge:
___________________________________________________________________
Name
_____________________________________________________
______________
Title
Date
Medical Waste Regulations 62 of 66
APPENDIX III:
MEDICAL WASTE TRANSPORTER REPORT
GENERAL INSTRUCTIONS FOR COMPLETING THE
MEDICAL WASTE TRANSPORTER REPORT
Transporters who are required to obtain a
Medical Waste Transporter Permit (pursuant to
Section 14.2 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 14.13 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
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
Medical Waste Regulations 63 of 66
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 quantity and units 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.
Medical Waste Regulations 64 of 66
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 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 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 Regulations 65 of 66
APPENDIX IV:
LIST OF ANIMAL DISEASES ASSOCIATED WITH ISOLATION WASTE
A. Isolated animals believed to be infected with highly communicable zoonotic diseases or
foreign animal diseases.
ANY SPECIES
Borna diseaase
Burkholderia mallei
Burkholderia pseudomallei
Nipah virus
Rift Valley Fever
Vesicular Exanthema of Swine (infection
with VESV)
AVIAN
Avian Influenza (high pathogenicity and
foreign strains)
Duck Virus Hepatitis
Exotic Newcastle disease
BOVINE
Akabane Disease
Bovine ephemeral fever
Bovine Spongeform Encephalopathy (BSE)
Contagious Bovine Pleuropneumonia
Foot-and-Mouth Disease (Aphthovirus)
Hemorrhagic septicemia
Jembrana desease
Rinderpest
CAPRINE/OVINE
Capripoxviruses
Contagious Caprine Pleuropneumonia
Malignant Catarrhal Fever
Peste des Petits Ruminants
Goat and sheep pox
EQUINE
African Horse Sickness
Epizootic Lymphangitis
Hendra
Venezuelan Equine Encephalomyelitis
(VEE)
PORCINE
African Swine Fever
Classical Swine Fever
Swine Vesicular Disease
Other
Rabbit Hemorrhagic Disease
Infectious Salmon Anemia
Spring Viremia of Carp
Medical Waste Regulations 66 of 66
APPENDIX V: HIGHLY COMMUNICABLE ENDEMIC ANIMAL DISEASES
Disease
Zoonosis
Carcass
Infectious
Special consideration
Any Species
Anthrax
Yes
Yes
Spores difficult to mitigate/small animals should be dealt with as
infectious waste/large animals buried with DEM approval
Brucellosis
Yes
Yes
Routine bagging and burial or incineration of small animals/large
animals buried with DEM approval
Leptospirosis
Yes
Yes if
contaminated
Routine bagging and burial or incineration of small animals/large
animals buried with DEM approval
Lymphocytic
Yes
Yes if
contaminated
Routine bagging and burial or incineration of small animals
Choriomeningitis
Plague
Yes
No
Flea vectors are required for transmission/routine disposal bagging
and burial or incineration
Q-Fever
Yes
Yes if
contaminated
Routine bagging and burial or incineration of small animals/large
animals buried with DEM approval
Rabies
Yes
Yes if
contaminated
Routine bagging and burial or incineration of small animals/large
animals buried with DEM approval
Tuberculosis
Yes
Yes
Routine bagging and burial or incineration of small animals/large
animals buried with DEM approval
Tularemia
Yes
Yes
Routine bagging and burial or incineration of small animals
Avian
Avian Influenza
Possible
Yes
Carcasses must be disposed of in a manner consistent with RI's AI
response plan
(Low Path)
Salmonellosis
Yes
Yes if
contaminated
Routine bagging and burial or incineration
Bovine
Malignant
Catarr-
No
No
Disposal by burial is acceptable
hal fever
Pseudorabies
No
Yes to
animals
Disposal by burial is acceptable
Canine
Canine
Influenza
No
Possibly
Routine bagging and burial or incineration
Parvovirus
No
Possibly
Routine bagging and burial or incineration
Caprine/Ovine
Bluetongue
No
No
Disposal by burial is acceptable
Caseous
Rare
Disposal by burial is acceptable
Lymphadenitis
Scrapie
No
Yes to
animals
Prion Disease, high temp or chemical digestion only
Equine
Equine Rhino-
No
Yes to
horses
Disposal by burial is acceptable
pneumonitis
Equine Viral
No
Unlikely
Disposal by burial is acceptable
Arteritis
Strangles
No
Yes if
contaminated
Disposal by burial is acceptable
Porcine
Hog Cholera
No
Yes
Disposal by burial is acceptable
Pseudorabies
No
Yes to
animals
Disposal by burial is acceptable