250 R.I. Code R. 250-RICR-140-15-1.2

Current through October 15, 2024

Section 250-RICR-140-15-1.2 - Purpose, Scope, and Applicability

A. Purpose- These Rules and Regulations serve the following purposes:

1. 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.

2. To establish comprehensive standards and procedures governing the generation, transportation, storage, treatment, destruction and disposal of regulated medical waste.

3. To establish a program for tracking medical waste shipments pursuant to R.I. Gen. Laws Chapter 23-19.12.

4. 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.

5. To establish a program for evaluating technologies for treating and/or destroying regulated medical waste.

B. Scope and Applicability:

1. These regulations shall apply to persons who generate, transport, store, treat, manage and/or dispose of regulated medical waste as defined in § 1.5 of this Part.

2. 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.

3. 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.

4. 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.

5. In certain situations involving outbreaks, or suspected outbreaks, of certain highly communicable diseases (either human or animal) the Director, in consultation with the 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.

6. 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.

C. 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 Part but is not excluded or exempted in § 1.2(D) of this Part. 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:

1. 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.

2. Animal Pathological Waste: Contaminated animal carcasses, body parts, and bedding of animals that were known to have either:

a. Been exposed to infectious agents during research, including research in veterinary hospitals, production of biologicals, or testing of pharmaceuticals; or,

b. Been infected with highly communicable endemic diseases that are indicated in § 1.22 of this Part, Appendix II to require special handling of carcasses and other materials.

3. 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).

4. Human Blood, Body Fluids and Blood Products:

a. Liquid waste human bloods or body fluids;

b. Products of blood;

c. Items saturated and/or dripping with human blood or body fluids;

d. 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,

e. Specimens of body fluids and their containers.

5. 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 these regulations, disposable syringes and needles are considered regulated medical waste after one use. The following categories of wastes are considered sharps:

a. 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.

b. 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 is not by definition Regulated Medical Waste.

c. 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.

d. 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.

6. 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 § 1.21 of this Part, Appendix I. The Director may update this list as new diseases are identified.

7. Spill/Cleanup Material: Any material collected during or resulting from the cleanup of a spill of regulated medical waste.

8. 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.

9. 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.

D. Regulated Medical Waste - Exclusions and Exemptions: The following categories of medical waste are specifically excluded from the definition of regulated medical waste:

1. Hazardous Waste Materials identified or listed under DEM Rules and Regulations for Hazardous Waste Management (Subchapter 10 Part 1 of this Chapter). 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 (Subchapter 10 Part 1 of this Chapter).

2. Household Medical Waste

a. 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.

b. 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,

c. Medical waste generated and disposed of with residential solid wastes from a single family residential premises or single family dwelling unit shall be exempt from these regulations except where such medical waste is generated from commercial or professional offices.

d. 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.

3. 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 § 1.2(D)(1) of this Part.

4. 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.

5. 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.

6. 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.

7. 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.

250 R.I. Code R. 250-RICR-140-15-1.2

Amended effective 4/22/2020