Administrative Code

Virginia Administrative Code
10/6/2022

Part IV. General Requirements

Article 1
Permits and on-Site Permits by Rule

9VAC20-120-160. Permit required.

Article 1
Permits and On-site Permits by Rule

No person who is subject to this chapter shall treat, store, or dispose of regulated medical waste without a permit from the department to engage in those activities. Any person required to have a permit for the management of regulated medical waste shall submit an application for a permit in accord with Part X (9VAC20-120-680 et seq.) of this chapter, with the exception that certain facilities deemed to have an on-site permit by rule in accordance with 9VAC20-120-180.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.1, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-170. Exemptions from permitting.

A. The holding of regulated medical waste on loading docks or areas designated for loading shall not require an on-site permit by rule or a permit under Part X (9VAC20-120-680 et seq.) of this chapter if:

1. The regulated medical wastes are packaged, marked, and labeled for transport in accordance with applicable requirements of subdivision 4 of 9VAC20-120-210.

2. The facility merely facilitates transportation and does not involve holding of regulated medical waste for more than 24 hours.

3. No more than 25% of the regulated medical waste at the loading dock is generated off-site.

4. While regulated medical waste is present, the area is secure from unauthorized access, and means are provided to prevent damage to the packaging by the elements or other factors.

B. Facilities generating 100 gallons per week or more of regulated medical waste shall not be required to hold an on-site permit by rule for storage or a permit for storage under Part X of this chapter if:

1. A designated storage area is provided for all areas of the facility accumulating in excess of 200 gallons of regulated medical waste. Designated storage areas shall meet the special requirements for storage facilities in Part V (9VAC20-120-330 et seq.) of this chapter.

2. All regulated medical waste stored in a designated storage area is properly packaged in accordance with the provisions of 9VAC20-120-210 and labeled in accordance with the provisions of 9VAC20-120-220.

3. While regulated medical waste is in storage, the first date the RMW is placed in storage is affixed to the outer packaging.

4. No more than 25% of the regulated medical waste received at the facility is generated off-site.

5. Regulated medical waste is not treated on-site.

C. Facilities generating less than 100 gallons per week of regulated medical waste shall not be required to hold an on-site permit by rule for storage or a permit for storage under Part X of this chapter or maintain records as required under 9VAC20-120-310 if:

1. Regulated medical waste is not held on-site in quantities greater than 200 gallons.

2. Regulated medical waste is accumulated and held in a safe and secure manner ensuring the waste cannot spill, or contact workers or the general public.

3. When regulated medical waste is ready to be discarded, the generator complies with the provisions for loading docks or areas designated for loading in 9VAC20-120-170 A.

4. Regulated medical waste is not treated on-site.

D. If a facility does not meet the above requirements for the storage of regulated medical waste, that facility is required to obtain an on-site permit by rule for on-site storage in accordance with the provisions of 9VAC20-120-180.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.2, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-180. Persons qualifying for an on-site permit by rule.

Qualifying facilities are deemed to operate under a permit for regulated medical waste management activities and their owners or operators are not required to comply with the permit issuance procedures of Part X (9VAC20-120-680 et seq.) of this chapter. While persons who own or operate qualifying facilities are not subject to Part X or required to have a written permit from the department for those qualifying facilities, they are subject to this chapter and all other parts thereof. If a person owns or operates a regulated medical waste management unit that does not qualify for an on-site permit by rule, that person must comply with Part X and all other parts of this chapter for those units, without regard to the presence of any other units on the site that are operated under a permit by rule. Only those units that are in complete compliance with all the following conditions are qualified and considered to be under an on-site permit by rule for their operation, and no on-site permit by rule shall exist for a facility failing to fulfill any of the following conditions:

1. The facility and all regulated medical waste activities are in compliance with all parts of this chapter except Part X.

2. More than 75% (by weight, in a calendar year) of all regulated medical waste that is stored, treated or disposed of by the facility is generated on-site.

3. No regulated medical waste is transported from or received by the facility without being properly packaged and labeled in accordance with this chapter. Facilities storing regulated medical waste will indicate the first date that the waste was placed in storage date on the outer packaging of the regulated medical waste.

4. The activities at the facility do not involve the placing of regulated medical waste directly into or on the land.

5. The owner or operator of the facility has notified the director in writing that the facility is operating under an on-site permit by rule. The notice shall give the name of the facility; the mailing address of the facility; the location address of the facility; the type of business the facility serves; the type of facilities (treatment, storage, transportation, disposal) involving regulated medical waste; and the name, address and telephone number of the responsible party indicated on the disclosure statement as required in subdivision 7 of this section.

6. The owner or operator of the facility has submitted to the director a certification from the local governing body (city, county, or town in which the facility is to be located) stating, without qualifications, conditions, or reservations, that the location and operation of the facility are consistent with all applicable ordinances.

7. The owner or operator of the facility has submitted to the director appropriate Key Personnel Disclosure Statements.

8. The facility will be operated by an individual certified by the Board of Waste Management Facility Operators.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.3, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

Article 2
Financial Assurance

9VAC20-120-190. Financial assurance requirements.

Article 2
Financial Assurance

The department has adopted and will maintain a separate regulation, the Financial Assurance Regulations for Solid Waste Facilities, which 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.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.4, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

Article 3
Packaging and Labeling Requirements for Regulated Medical Waste

9VAC20-120-200. Responsibility for packaging and labeling.

Article 3
Packaging and Labeling Requirements for Regulated Medical Waste

A. The generator of regulated medical waste is responsible for the packaging and labeling of regulated medical wastes. As a bag or container becomes full, it must be sealed, labeled and managed as described in this chapter. Contractors or other agents may provide services to the generator, including packaging and labeling of regulated medical waste, however, no contract or other relationship shall relieve the generator of the responsibility for packaging and labeling the regulated medical waste as required by this chapter.

B. No person shall receive for transportation, storage or treatment any regulated medical waste that is not packaged and labeled in accordance with this chapter. Contractors or other agents may package or repackage regulated medical wastes to comply with this chapter, if the packaging or repackaging is performed on-site where the regulated medical waste was generated and no transportation, storage, treatment or disposal occurs prior to the packaging or repackaging. Nothing in this section shall prevent the proper repackaging and further transportation of regulated medical waste that has spilled during transportation.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.5, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-210. Packaging prior to storage, treatment or transport.

All regulated medical waste shall be packaged as follows:

1. When regulated medical wastes are discarded, they shall be placed in containers meeting the requirements of the standards for occupational exposure to bloodborne pathogens in the general industry standard in 16VAC25-90-1910.1030. The general industry standard requires the packaging to be closable, constructed to prevent leakage, labeled with the biohazard symbol, and closed to prevent spillage during handling. Upon being placed in storage, red bags shall be used for the packaging of all regulated medical waste except as provided in subdivision 2 of this section. Packaging shall be labeled as provided for in 9VAC20-120-220.

2. Contaminated sharps shall be placed directly in containers as required by the general industry standards in 16VAC25-90-1910.1030. The containers shall be labeled as provided for in 9VAC20-120-220.

3. As bags and containers become full, they shall be sealed such that no waste materials can leak.

4. Prior to transporting regulated medical waste, waste will be packaged for transportation in accordance with the standards of 49 CFR Part 173 or packaged in accordance with an exemption approved by the United States Department of Transportation.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.6, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-220. Labeling requirements.

Waste packaged under subdivisions 1 or 2 of 9VAC20-120-210 shall be labeled. The label shall be securely attached to or printed on packaging. The label may be a tag securely affixed to the package. Indelible ink shall be used to complete the information on the label. The label and the information provided on the label must be clearly legible. The following information shall be included:

1. The name, address and business telephone number of the generator.

2. "Regulated Medical Waste" in large print.

3. The Biological Hazard Symbol.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.7, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-230. Etiological agents.

All etiological agents, as defined in 49 CFR Parts 171 through 178, that are transported must be packaged and labeled as described in 49 CFR Parts 171 through 178.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.8, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, June 19, 2002.

9VAC20-120-240. Sharps.

Sharps must be placed directly into puncture resistant containers as required by the general industry standards in 16VAC25-90-1910.1030(d)(4)(iii)(A).

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.9, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-250. Protection of packagers.

Persons packaging regulated medical waste shall wear appropriate items of personal protective equipment.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.10, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-260. Special requirements for reusable containers.

Regulated medical waste may be conveyed in reusable carts or containers under the following conditions:

1. The waste in the cart or container is packaged and labeled fully in accordance with 9VAC20-120-210 through 9VAC20-120-240.

2. Immediately following each time a reusable cart or container is emptied and prior to being reused it is thoroughly cleaned with detergent or general purpose disinfectant.

3. When reusable carts or containers containing regulated medical waste are used for off-site transport, all aspects of the cart or container management shall comply with federal Department of Transportation Hazardous Material Regulations 49 CFR Parts 171 to 178, as applicable.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.11, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

Article 4
Management of Spills of Regulated Medical Waste

9VAC20-120-270. Spill containment and cleanup kit.

Article 4
Management of Spills of Regulated Medical Waste

All regulated medical waste management facilities are required to keep a spill containment and cleanup kit within the vicinity of any area where regulated medical wastes are managed, and the location of the kit shall provide for rapid and efficient cleanup of spills anywhere within the area. All vehicles transporting regulated medical wastes are required to carry a spill containment and clean up kit in the vehicle whenever regulated medical wastes are conveyed. The kit shall consist of at least the following items:

1. Material designed to absorb spilled liquids. The amount of absorbent material shall be that having a capacity, as rated by the manufacturer, 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 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 at a distance. The disinfectant shall be hospital grade and effective against mycobacteria.

3. Enough red plastic bags to enclose 150% of the maximum load accumulated or transported (up to a maximum of 500 bags), that meet the applicable requirements of 49 CFR Part 173 or an exemption approved by the United States Department of Transportation. These bags shall be large enough to overpack any box or other container normally used for regulated medical waste management by that facility.

4. Appropriate personal protective equipment.

5. For vehicles only, a first aid kit, fire extinguisher, boundary marking tape, lights and other appropriate safety equipment.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.12, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-280. Containment and cleanup procedures.

Following a spill of regulated medical waste or its discovery, the following procedures shall be implemented:

1. Take appropriate precautions to ensure personnel do not come into contact with any contaminants by wearing appropriate personal protective equipment.

2. Repackage spilled waste in accordance with the packaging requirements in 9VAC20-120-210.

3. Transport any regulated medical waste by a transporter that meets the requirements of Part VI (9VAC20-120-400 et seq.) of this chapter.

4. Clean and disinfect any areas having been contacted by regulated medical wastes. Materials used to decontaminate the area will be disinfectants effective against mycobacteria.

5. Take necessary steps to replenish containment and cleanup kit.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.13, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002; Volume 29, Issue 19, eff. July 4, 2013.

Article 5
Closure Requirements

9VAC20-120-290. Closure requirements.

Article 5
Closure Requirements

When a unit that has been used for regulated medical waste management is to cease operations involving regulated medical wastes, it shall be thoroughly cleaned and disinfected. All regulated medical waste shall be disposed of in accord with this chapter, and items of equipment shall be decontaminated.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.14, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

Article 6
Treatment and Disposal

9VAC20-120-300. Methods of treatment and disposal.

Article 6
Treatment and Disposal

A. All regulated medical waste must be incinerated, sterilized by steam, or treated by a method as described in Part VII (9VAC20-120-520 et seq.), VIII (9VAC20-120-580 et seq.), or IX (9VAC20-120-630 et seq.) of this chapter.

B. No regulated medical waste shall be disposed of in a solid waste landfill or other solid waste management facility. Upon authorized treatment and management in accord with this chapter, the solid waste or its ash is not regulated medical waste and may be disposed of at any landfill or other solid waste management facility permitted to receive municipal solid waste or garbage, provided the disposal is in accordance with the Solid Waste Management Regulations, 9VAC20-81, and other applicable regulations and standards.

C. Regulated medical waste in closed bags or containers shall not be compacted or subjected to violent mechanical stress; however, after it is fully treated and it is no longer regulated medical waste, it may be compacted in a closed container. Nothing in this section shall prevent the puncturing of containers or packaging immediately prior to permitted treatment in which grinding, shredding, or puncturing is integral to the process units; however, all grinding, shredding and puncturing shall be done with safe and sanitary methods. Nothing in this section shall prevent the use of devices that grind, shred or compact to reduce volume at the point of generation. Devices will be constructed in a manner that prevents employee exposure to the waste, contains any aerosol or mist that may be caused by the process, and treats or filters any air evacuated from the chamber during processing. These devices may be employed at the point of generation and prior to enclosing the regulated medical waste in plastic bags and other required packaging; however, the waste remains regulated medical waste. Appropriate means must be employed to appropriately protect workers and contain the waste when unloading regulated medical wastes from such a device.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.15, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002; Volume 27, Issue 22, eff. August 3, 2011.

Article 7
Recordkeeping

9VAC20-120-310. Recordkeeping requirements.

Article 7
Recordkeeping

A. Unless a generator is exempt from this requirement under the provisions of 9VAC20-120-170 C, generators and regulated medical waste management facilities that manage regulated medical waste shall maintain the following records and assure that they are accurate and current:

1. A list of the members of any committee for the management of infection control for the facility, their address, their phone numbers and the period of their membership.

2. The date, persons involved and short description of events in each spill of more than 32 gallons of regulated medical waste or one quart of regulated medical waste consisting of free liquid.

3. A notebook or file containing the adopted policies and procedures of the facility for dealing with regulated medical wastes.

4. A log of all special training received by persons involved in regulated medical waste management.

5. A log of regulated medical waste received from off-site, the generator, the amount and its storage and receipt dates. Records shall be maintained for a period of three years and be available for review.

B. All regulated medical waste management facilities shall maintain the following records and assure that they are accurate and current:

1. A signed certificate for each load received in which the generator affirms that the load does not contain hazardous waste (including cytotoxic medications) or radioactive materials, except as provided in 9VAC20-120-320; or

2. A signed and effective contract, inclusive of all loads received from a generator, in which the generator affirms that all loads will not contain hazardous waste (including cytotoxic medications) or radioactive materials, except as provided in 9VAC20-120-320.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.16, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

Article 8
Radioactive Materials

9VAC20-120-320. Management of radioactive materials.

Article 8
Radioactive Materials

The United States Nuclear Regulatory Commission (USNRC) has established regulations under Title 10 of the Code of Federal Regulations for the 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 not to represent a threat to public health and the environment.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 4.17, eff. June 29, 1994.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.