Part II. General Information
9VAC20-121-20. Purpose.
The purpose of this chapter is to establish standards and procedures pertaining to regulated medical waste management in the Commonwealth of Virginia in order to protect the public health and public safety, and to enhance the environment and natural resources.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-30. Administration.
A. The Virginia Waste Management Board promulgates and enforces regulations that it deems necessary to protect the public health and safety, the environment, and natural resources.
B. The director is authorized and directed to administer this chapter in accordance with the Virginia Waste Management Act (§§ 10.1-1400 through 10.1-1457 of the Code of Virginia).
C. Nothing in this chapter shall limit or affect the power of the director, by the director's order, to prohibit storage, transfer, treatment, or disposal of any waste or require special handling requirements the director determines are necessary to protect the public health or the environment.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-40. Applicability.
A. This chapter applies (i) to all persons who generate or transport, store, transfer, process, treat, dispose, or otherwise manage regulated medical waste; own or operate a regulated medical waste management facility; or allow a regulated medical waste management facility to be operated on their property in the Commonwealth of Virginia; and (ii) to those who seek approval to engage in these activities, except those specifically exempted or excluded elsewhere in this chapter. A "person" may include an individual, firm, company, corporation, partnership, association, state or federal government and any agency thereof, municipality, commission, political subdivision of a state, or any interstate body.
B. All existing regulated medical waste management facilities must comply with this chapter. Existing facilities, including those with an existing permit, must submit updated permit application documents by September 15, 2024, to come into compliance with this chapter. If the updated application includes changes that result in a different type of facility as outlined in 9VAC20-121-300 C 2, a complete permit-by-rule application shall be required. Existing facilities that only make changes to come into compliance with the regulations shall submit the following updated documents, as applicable, in accordance with 9VAC20-121-310:
1. DEQ Form RMW PBR;
2. Disclosure statements (DEQ Form DISC-01 and DISC-02), if changes in key personnel;
3. Design and construction certification by a professional engineer, in accordance with 9VAC20-121 310 A 2 c;
4. Design plans in accordance with 9VAC20-121-310 A 2 d;
5. Facility standards certification and a copy of the Regulated Medical Waste Management Plan in accordance with 9VAC20-121-310 A 2 f;
6. Treatment Plan in accordance with 9VAC20-121-310 A 2 h and i, respectively;
7. Closure Plan and closure cost estimate, in accordance with 9VAC20-121-310 A 2 j and m;
8. Certification from the State Corporation Commission, in accordance with 9VAC20-121-310 A 2 l, if not previously provided; and
9. Applicable permit fee in accordance with 9VAC20-121-310 A 2 n.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-50. Prohibitions.
A. No person shall operate any regulated medical waste management facility for the transfer, treatment, or disposal of regulated medical waste without a permit from the director.
B. No person shall allow regulated medical waste to be stored, disposed, or otherwise managed on the person's property except in accordance with this chapter.
C. It shall be the duty of all persons to manage their regulated medical waste in a legal manner. Untreated regulated medical waste, including its packaging, shall not be used, reused, or reclaimed.
D. No person shall:
1. Allow regulated medical waste to drain or discharge into surface waters except when treated onsite and discharged into surface water as authorized under a Virginia Pollutant Discharge Elimination System (VPDES) Permit (9VAC25-31).
2. Cause the discharge of pollutants into waters of the United States, including wetlands, that violates any requirements of the Clean Water Act (33 USC § 1251 et seq.), including the VPDES requirements and Virginia Water Quality Standards (9VAC25-260).
3. Cause the discharge of a nonpoint source of pollution to waters of the United States, including wetlands, that violates any requirement of an area wide or statewide water quality management plan that has been approved under § 208 or 319 of the Clean Water Act (33 USC § 1251 et seq.) or violates any requirement of the Virginia Water Quality Standards (9VAC25-260).
4. Allow regulated medical waste to be deposited in or to enter any surface waters, groundwaters, or storm drains.
E. Any person who violates subsection A, B, C, or D of this section shall immediately cease the activity of improper management and shall initiate waste removal, cleanup, or closure.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-60. Enforcement and appeal.
A. All administrative enforcement and appeals taken from actions of the director relative to the provisions of this chapter shall be governed by the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).
B. The Virginia Waste Management Board or the director may enforce the provisions of this chapter utilizing all applicable procedures under the law. The powers of the board and the director include those established under Chapter 11.1 (§ 10.1-1182 et seq. of the Code of Virginia); in Article 8 (§ 10.1-1455 et seq.) of Chapter 14 of Title 10.1 of the Code of Virginia; and particularly in § 10.1-1186 of the Code of Virginia. These sections describe the right of entry for inspections; the issuance of orders, penalties, injunctions; and other provisions and procedures for enforcement of this chapter.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-70. Public participation and information.
A. All permits for regulated medical waste management facilities are subject to public participation, as specified in Part V (9VAC20-121-300 et seq.) of this chapter.
B. Modifications to regulated medical waste management facility permits shall be subject to public participation in accordance with Part V (9VAC20-121-300 et seq.) of this chapter.
C. Dockets of all permitting actions, enforcement actions, and administrative actions relative to this chapter shall be available to the public for review, consistent with the Virginia Administrative Process Act, Virginia Freedom of Information Act (§ 2.2-3700 of the Code of Virginia), and the provisions of this chapter.
D. Public participation in the compliance evaluation and enforcement programs is encouraged. The department will:
1. Investigate all citizen complaints and provide written responses to all signed, written complaints from citizens, concerning matters within the board's purview;
2. Not oppose intervention by any citizen in a suit brought before a court by the department as a result of the enforcement action; and
3. Provide notice on the department's website and provide at least 30 days of public comment on proposed settlements of civil enforcement actions, except where the settlement requires some immediate action. Where a public comment period is not held prior to the settlement of an enforcement action, public notice will still be provided following the settlement.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-80. Relationship to other bodies of regulation.
A. The Solid Waste Management Regulations (9VAC20-81) address other requirements for solid waste management. If there is a conflict between the provisions of this chapter and the solid waste management regulations, this chapter is controlling.
B. Regulated medical waste management facilities must also comply with any applicable sections of the Hazardous Waste Management Regulations (9VAC20-60). If there is a conflict between the provisions of this chapter and the hazardous waste management regulations, 9VAC20-60 is controlling.
C. Intrastate shipment of hazardous materials is subject to the Regulations Governing the Transportation of Hazardous Materials (9VAC20-110). If there is a conflict between the provisions of this chapter and the hazardous materials transportation regulations, 9VAC20-110 is controlling.
D. Generators of regulated medical waste and regulated medical waste management facilities may be subject to the general industry standard for occupational exposure to bloodborne pathogens in 16VAC25-90-1910.1030 (29 CFR 1910.1030).
E. Persons transporting regulated medical waste are subject to the federal requirements in the U.S. Department of Transportation Hazardous Material Regulations at 49 CFR Parts 171 through 180.
F. Facilities managing select agents or toxins are subject to the Regulations for Disease Reporting and Control (12VAC5-90) as administered by the Virginia Department of Health. Facilities that possess, use, or transfer select agents or toxins are also subject to registration, reporting, inactivation, destruction, and compliance with the U.S. Department of Health and Human Services and U.S. Department of Agriculture's Federal Select Agent Program and the federal select agent regulations at 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.
G. If there is a conflict between provisions of this chapter and adopted regulations of another agency of the Commonwealth, the provisions of these regulations are set aside to the extent necessary to allow compliance with the regulations of the other agency. If neither regulation controls, the more stringent standard applies.
H. Nothing in this chapter either precludes or enables a local governing body to adopt ordinances. Compliance with one body of regulation does not ensure compliance with the other, and normally, both bodies of regulation must be fully complied with.
I. The Financial Assurance Regulations for Solid Waste Disposal, Transfer, and Treatment Facilities (9VAC20-70) shall be applicable in all parts to regulated medical waste management facilities. Nothing in this chapter governing regulated medical waste management shall be considered to delete or alter any requirements of the department as set out in Financial Assurance Regulations for Solid Waste Facilities.
J. The U.S. Nuclear Regulatory Commission, 10 CFR, regulates management of radioactive materials. The Virginia Department of Health has established other requirements in accordance with Title 32.1 of the Code of Virginia. No regulated medical waste containing radioactive materials, regardless of amount or origin, shall be treated unless its management and treatment are in full compliance with these two bodies of regulations and are deemed by both regulations to represent no threat to public health and the environment.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-90. Identification of regulated medical waste.
A. A solid waste is a regulated medical waste subject to this chapter if it meets the criteria under subsection B of this section, unless specifically excluded or exempted by subsection C or D of this section. Claims that materials are not regulated medical wastes or are conditionally exempt from regulation shall demonstrate that the material meets the terms of an exemption. In doing so, appropriate documentation shall be provided to demonstrate that the material is not a regulated medical waste or is exempt from regulation.
B. A solid waste is a regulated medical waste if it meets either of the two criteria of this subsection:
1. The solid waste is suspected by the health care professional in charge of being capable of producing an infectious disease in humans. A solid waste shall be considered to be capable of producing an infectious disease if it has been or is likely to have been contaminated by an organism likely to be pathogenic to healthy humans, such organism is not routinely and freely available in the community, and if such organism has a significant probability of being present in sufficient quantities and with sufficient virulence to transmit disease. If the exact cause of a patient's illness is unknown, but the health care professional in charge suspects a contagious disease is the cause, the likelihood of pathogen transmission shall be assessed based on the pathogen suspected of being the cause of the illness.
2. The solid waste or solid waste stream is identified in the following list:
a. Discarded cultures, stocks, specimens, vaccines, and associated items likely to have been contaminated by them are regulated medical wastes if they are likely to contain organisms likely to be pathogenic to healthy humans. Wastes from the production of biologicals and antibiotics likely to have been contaminated by organisms likely to be pathogenic to healthy humans are regulated medical wastes;
b. Wastes consisting of human blood or body fluids, containers of human blood or body fluids, and items contaminated with human blood or body fluids are regulated medical waste. Human blood and body fluids solidified by absorbent gel, powder, or similar means are also regulated medical waste.
c. Human pathological and anatomical waste, including tissues, organs, body parts, and other pathological or anatomical wastes;
d. Sharps likely to be contaminated with a pathogen or that may become contaminated with a pathogen through handling or during transportation and also capable of cutting or penetrating skin or a packaging material. This also includes sharps generated through veterinary practice, acupuncture needles, and household sharps collected in a sharps drop box;
e. When animals are intentionally infected with organisms likely to be pathogenic to healthy humans for the purposes of research, in vivo testing, production of biological materials, or any other reason, the animal carcasses, body parts, bedding material, and all other wastes likely to have been contaminated are regulated medical wastes when discarded, disposed of, or placed in storage;
f. Wastes that are contaminated with a Category A infectious substance are regulated medical waste that shall be managed in accordance with 9VAC20-121-160;
g. Any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill of any regulated medical waste; and
h. Any solid waste contaminated by or mixed with regulated medical waste, including solid wastes that are packaged as regulated medical wastes.
C. The following materials are not solid wastes or regulated medical wastes:
1. Domestic sewage, including wastes that are not stored and are disposed of in a sanitary sewer system (with or without grinding).
2. Any mixture of domestic sewage and other wastes that pass through a sewer system to a wastewater treatment works permitted by the State Water Control Board or the Virginia Department of Health.
3. Sanitary waste from septic tanks (septage) and sewage holding tanks that is regulated by other state agencies.
4. Human remains when:
a. Under the control of a licensed physician or dentist, when the remains are being used or examined for medical purposes and are not solid wastes;
b. Provided to qualified educational programs as anatomical gifts;
c. 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
d. Properly interred in a cemetery or in preparation by a licensed funeral director or embalmer for such interment or cremation.
5. Individual human and animal cremains.
6. Dead or diseased animals subject to regulation by the Virginia Department of Agriculture and Consumer Services.
7. Bed linen, instruments, medical care equipment, and other materials that are routinely cleaned and reused for their original purpose are not subject to this chapter until they are discarded and are a solid waste unless a health care professional has determined these items to be to be capable of producing an infectious disease in humans in accordance with subdivision B 1 of this section. These items do not include reusable carts or containers used in the management of regulated medical waste, which shall be managed in accordance with 9VAC20-121-130.
8. Used health care products and reusable medical devices, being returned to a manufacturer or third party for reprocessing (cleaning and disinfecting or sterilizing) and reuse if packaged and labeled in accordance with 49 CFR 173.134(b)(12)(ii)(A) through (D) and reprocessed in accordance with applicable U.S. Food and Drug Administration requirements. Used health care products and contaminated medical devices or equipment that meet either of the two criteria in subsection B of this section being sent offsite for recycling or disposal are regulated medical waste and shall be managed in accordance with this chapter. These items do not include reusable carts or containers used in the management of regulated medical waste, which shall be managed in accordance with 9VAC20-121-130.
9. The following items while in use: samples for laboratory tests, patient specimens, and criminal evidence items taken during enforcement procedures that meet the definition of regulated medical waste. Once these items are no longer needed for their intended purpose, they shall be managed as regulated medical waste unless exempt under subsection D of this section.
10. Tissue blocks of organs or tissues (except those associated with prions) that have been fixed in paraffin or similar embedding materials for cytological or histological examinations. Once these items are no longer needed for their intended purpose, they may be managed as solid waste.
D. The following solid wastes are not regulated medical wastes for purpose of this chapter:
1. Wastes that have been treated in accordance with this chapter are no longer regulated medical waste and may be used, reused, or reclaimed in accordance with the provisions of the Virginia Solid Waste Management Regulations (9VAC20-81), provided the following requirements are met:
a. Treated waste that was once regulated but is no longer regulated medical waste shall not be repackaged as regulated medical waste. Solid waste repackaged as regulated medical waste is regulated medical waste.
b. If the solid waste is no longer regulated medical waste because of treatment, the generator and the permitted treatment facility shall maintain a record of the treatment for three years after treatment. Generators treating regulated medical waste onsite shall maintain records in accordance with applicable provisions of Part V (9VAC20-121-300 et seq.) of this chapter. Generators shipping regulated medical waste offsite for treatment shall maintain records in accordance with 9VAC20-121-100 I.
c. The generator or proposed user of treated regulated medical waste may request that the department make a case-specific determination that the solid waste may be beneficially used in a manufacturing process to make a product or as an effective substitute for a commercial product. The requestor shall submit a beneficial use demonstration in accordance with the requirements of 9VAC20-81-97.
2. Household waste, including household sharps. Household sharps shall be placed in an opaque, leak proof, puncture resistant container that is closed, tightly sealed, and labeled for home use before being mixed with other solid wastes or disposed. Household sharps may be placed in U.S. Food and Drug Administration-cleared sharps containers if specifically designed and labeled for home use. Household sharps containers shall be labeled "HOUSEHOLD SHARPS – DO NOT RECYCLE" or "HOME GENERATED SHARPS – DO NOT RECYCLE" printed in large legible text and permanent ink. Household sharps centrally collected in a sharps drop box shall be managed as regulated medical waste in accordance with 9VAC20-121-300 E 1. Medical waste generated by a health care professional administering care in a household is regulated medical waste and must be managed in accordance with this chapter.
3. Nail and skin clippings, breast milk, sputum, semen, teeth, sweat, tears, urine, vomitus, or saliva, unless contaminated with visible blood or a health care professional has determined these items to be capable of producing an infectious disease in humans in accordance with subdivision B 1 of this section.
4. Dental amalgam managed in accordance with the Dental Rule (40 CFR Part 441).
5. Meat or other food items being discarded because of spoilage, contamination, or recall.
6. The following discarded 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 has determined these items to be capable of producing an infectious disease in humans in accordance with subdivision B 1 of this section.
7. 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 to be capable of producing an infectious disease in humans in accordance with subdivision B 1 of this section.
8. 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 16VAC25-90-1910.1030 (29 CFR 1910.1030) or a comparable state or federal standard.
9. The following discarded items: urinary catheters, suction catheters, plastic cannula, IV spikes, nasogastic 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 16VAC25-90-1910.1030 (29 CFR 1910.1030) or a comparable state or federal standard.
10. 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.
11. Human blood and body fluids when solidified by absorbent gel, powder, or similar means as part of a 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.
12. 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 generated through veterinary practice that meets either of the two criteria of subsection B of this section, such as sharps, must be managed as regulated medical waste.
13. Waste from cosmetology, ear and body piercing, nail salons, and tattoo establishments, except for sharps and unabsorbed human blood or body fluids.
14. 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.
15. 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.
16. 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.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.