Virginia DEQ
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Regulated Medical Waste
Changes to the Regulations
The Virginia Regulated Medical Waste Management Regulations (9VAC20-121) were recently amended, and the new regulations are effective March 15, 2023. DEQ's Summary of Significant Changes provides a high-level overview of Amendment 3 to the regulations, and the Crosswalk of Regulations clarifies the new location of each part and section in the current chapter (Chapter 121) compared to the previous chapter (Chapter 120). Background information on Amendment 3 is available on the Virginia Regulatory Town Hall website.
What is Regulated Medical Waste?
Regulated medical waste (RMW) is a subset of solid waste that is subject to more stringent management standards in order to prevent potential exposure to pathogens that could transmit an infectious disease.
The following types of solid wastes must be managed as regulated medical waste:
- Solid waste suspected by the health care professional in charge of being capable of producing infectious disease in humans
- Discarded cultures, stocks, specimens, vaccines, wastes from the production of biologicals and antibiotics, and associated items likely to be pathogenic to healthy humans
- Human blood or body fluids, and items contaminated with human blood or body fluids
- Human blood and body fluids solidified by absorbent gel, powder, or similar means (except when part of spill cleanup at establishments engaged in operations other than health care or management of regulated medical waste)
- Human pathological and anatomical waste, including tissues, organs, body parts, and other wastes
- Contaminated sharps, such as needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, exposed ends of dental wires, sharps generated through veterinary practice, and acupuncture needles
- Sharps drop boxes used to centrally collect household sharps as a convenience to the public
- Contaminated sharps and unabsorbed human blood or body fluids from cosmetology, ear and body piercing, nail salons, and tattoo establishments
- Animal carcasses and related wastes when animals are intentionally infected with organisms likely to be pathogenic to healthy humans
- Wastes contaminated with a Category A infectious substance (i.e., Category A Waste)
- Residues or contaminated materials from the cleanup of a spill of regulated medical waste
- Solid waste contaminated by or mixed with regulated medical waste
Certain solid wastes do not have to be managed as regulated medical waste and can be disposed of in the regular trash. Types of solid wastes that are NOT regulated medical waste include:
- Wastes that have been properly treated by a permitted RMW Treatment Facility
- Household waste (except for regulated medical waste generated by a health care professional administering care in a household)
- Household sharps (these items should be placed in opaque, leak proof, puncture resistant containers that are closed, sealed, and labeled for home use before disposing of them in the regular trash)
- Nail and skin clippings, breast milk, sputum, semen, teeth, sweat, tears, urine, vomitus, or saliva, unless any of these wastes are contaminated with visible blood or a health care professional has determined them to be capable of producing infectious disease in humans
- Dental amalgam managed in accordance with the Dental Rule (40 CFR Part 441)
- Meat or other food items discarded because of spoilage, contamination, or recall
- The following items, when they are unused or expired: health care products, medical equipment, medical devices, unused sharps in the original packaging, or other materials, unless a health care professional determines the items are capable of producing infectious disease in humans
- Used products for personal hygiene, such as diapers, facial tissues, underpads, adult incontinence products, sanitary napkins, and feminine hygiene items, unless a health care professional has determined these items are capable of producing infectious disease in humans
- The following discarded items when they are empty: urine collection bags and tubing, suction canisters and tubing, IV solution bags and tubing, colostomy bags, ileostomy bags, urostomy bags, plastic fluid containers, enteral feeding containers and tubing, hemovacs, urine bottles, and urine specimen cups, unless the items are subject to regulation under the Bloodborne Pathogen Standard or a comparable state or federal standard
- The following discarded items: urinary catheters, suction catheters, plastic cannula, IV spikes, nasogastric tubes, oxygen tubing and cannula, ventilator tubing, enema bags and tubing, enema bottles, thermometer probe covers, irrigating feeding syringes, and bedpans or urinals, unless the items are subject to the Bloodborne Pathogen Standard or a comparable state or federal standard
- Items such as bandages, gauze, or cotton swabs or other similar absorbent materials, unless at any time following use the items are saturated or would release human blood or human body fluids in a liquid or semiliquid state if compressed. Items that contain or that are caked with dried human blood or human body fluids and are capable of releasing these materials during handling are regulated medical waste. An item would be considered caked if it could release flakes or particles when handled.
- Human blood and body fluids when solidified by absorbent gel, powder, or similar means as part of spill cleanup at establishments engaged in operations other than health care or management of regulated medical waste. This category includes waste generated by stores, markets, office buildings, restaurants, businesses, schools, manufacturers, and commercial or industrial operations.
- Waste generated from the care of an animal when care is provided by the owner of the animal, such as at a household or farm
- Waste from cosmetology, ear and body piercing, nail salons, and tattoo establishments, except for sharps and unabsorbed human blood or body fluids
- Plant or animal wastes, such as bat guano, removed from construction or demolition projects when actions are taken to avoid worker exposure, including use of appropriate personal protective equipment, and the waste is managed in accordance with any applicable best management practice, special handling, and other precautions for processing or disposal
- Waste from food, drug, and cosmetics testing laboratories (except research laboratories) using microbiological methods for the detection of human infectious agents, microbial toxins, or chemical residuals as part of routine quality assurance testing of food, drugs, or cosmetic products
- Wastes regulated by the Virginia Department of Health, the State Water Control Board, the Air Pollution Control Board, Department of Agriculture and Consumer Services, Federal Drug Administration, U.S. Department of Agriculture, or any other state or federal agency with such authority
Materials that are NOT solid wastes or regulated medical waste include:
- Domestic sewage, and mixtures of domestic sewage and other wastes that pass through a sewer system to a permitted wastewater treatment works
- Sanitary waste from septic tanks and sewage holding tanks
- Human remains when:
- Under the control of a licensed physician or dentist, when the remains are being used or examined for medical purposes
- Provided to qualified educational programs as anatomical gifts
- Removed during a medical procedure and retained by the patient for religious or other purposes provided that the remains are not a source of disease transmission, as determined by a health care professional; or
- Properly interred in a cemetery or in preparation by a licensed funeral director or embalmer for such interment or cremation
- Individual human and animal cremains
- Dead or diseased animals regulated by the Virginia Department of Agriculture and Consumer Services
- Bed linen, instruments, medical care equipment, and other materials, when they are routinely cleaned and reused for their original purpose
- Used health care products and reusable medical devices when they are returned to a manufacturer or third party for reprocessing (cleaning and disinfecting or sterilizing) and reuse, if packaged and labeled in accordance with U.S. Food and Drug Administration requirements
- Samples for laboratory tests, patient specimens, and criminal evidence items taken during enforcement procedures, while these items are in use
- Tissue blocks of organs or tissues (except those associated with prions) fixed in paraffin or similar embedding materials for cytological or histological examinations
Household sharps are needles, syringes with attached needles, lancets, auto injectors, pen needles, and any other devices used to penetrate the skin for the delivery of medications, that are generated at home through self-care, rather than through the care of a home healthcare professional or at a healthcare facility.
Household sharps must NEVER be recycled, placed loosely or directly into the trash, or flushed down the toilet. DEQ’s Management of Household Sharps flyer outlines the steps that must be taken in order to safely dispose of household sharps. Mail-back programs for household sharps disposal may also be available, though disposal fees or vendor requirements may apply. Check with your local healthcare provider, pharmacy, or locality for more information as there may be options for safe disposal in your community.
When household sharps are centrally collected in a sharps drop box as a convenience to the public (such as in a public restroom, airport, train station, health clinic, pharmacy, health department, police or fire station, community building, permitted solid waste management facility, or other location), the drop box is required to be packaged, labeled, and managed as regulated medical waste.
Regulated Medical Waste Management Requirements
The Virginia Regulated Medical Waste Management Regulations (9VAC20-121) establish standards and procedures for the management of all RMW including proper packaging, labeling, storage, transport, transfer, treatment, and disposal.
Generators are subject to requirements for general handling, packaging, labeling, storage, reusable containers, spill kits and cleanup, transport, and recordkeeping in accordance with the Virginia Regulated Medical Waste Management Regulations (9VAC20-121). A high-level overview of applicable regulatory requirements is provided in the Compliance Assistance Document for Regulated Medical Waste Generators.
Generators are not required to obtain a permit from DEQ as long as they are not operating as a Transfer Station or Treatment Facility. Generators must arrange for removal of regulated medical waste and provide shipment offsite to a facility permitted to receive it for transfer, treatment, or disposal. Untreated regulated medical waste, including its packaging, must not be used, reused, reclaimed, recycled, or disposed of in the regular trash, or disposed of at a solid waste landfill or other solid waste management facility.
Transporters are not required to register with DEQ or obtain a permit from DEQ as long as they are not operating as a Transfer Station or Treatment Facility. Any vehicle containing regulated medical waste that is parked 24 hours or more during transport is considered a Transfer Station. Regulated medical waste must be transported to a facility permitted to receive it for transfer, treatment, or disposal. Untreated regulated medical waste, including its packaging, must not be used, reused, reclaimed, recycled, or disposed of in the regular trash, or disposed of at a solid waste landfill or other solid waste management facility.
Regulated Medical Waste Transfer Stations are facilities where regulated medical waste is received from off-site for subsequent consolidation, over-packing, storage, trans-loading, or transfer prior to transportation to another facility for further processing, treatment, transfer, or disposal. Any vehicle containing regulated medical waste that is parked 24 hours or more during transport is considered a Transfer Station.
Transfer Stations are required to obtain a permit from DEQ and are subject to requirements for siting, design and construction, operations, recordkeeping, reporting, and closure in accordance with the Virginia Regulated Medical Waste Management Regulations (9VAC20-121) A high-level overview of applicable regulatory requirements is provided in the:
- Compliance Assistance Document for Existing RMW Transfer Stations (facilities already holding a permit as of March 15, 2023)
- Compliance Assistance Document for Prospective RMW Transfer Stations
Transfer Stations are also subject to permit application fees, annual fees, financial assurance requirements, and operator certifications under other regulations.
Prior to disposal, all regulated medical waste must be treated at a permitted Regulated Medical Waste Treatment Facility using an approved treatment method, such as autoclaving, incineration, or an alternative treatment method.
Treatment Facilities are required to obtain a permit from DEQ and are subject to requirements for siting, design and construction, operations, treatment (including validation testing, challenge testing, and treated waste disposal), recordkeeping, reporting, and closure in accordance with the Virginia RMW Management Regulations (9VAC20-121). A high-level overview of applicable regulatory requirements is provided in the:
- Compliance Assistance Document for Existing RMW Treatment Facilities (facilities already holding a permit as of March 15, 2023)
- Compliance Assistance Document for Prospective RMW Treatment Facilities
Treatment Facilities are also subject to permit application fees, annual fees, financial assurance requirements, and operator certifications under other regulations.
Waste that has been properly treated at a permitted Regulated Medical Waste Treatment Facility in accordance with the requirements of the regulations is considered a solid waste that can then be disposed of at a permitted solid waste management facility (e.g., sanitary landfill), provided the facility’s permit allows for acceptance of the material.
