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Virginia

Regulated Medical Waste

Background Information
Definition of Regulated Medical Waste
Managing Regulated Medical Waste
Transporting Regulated Medical Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

 


Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Regulated Medical Waste (RMW)

In Virginia, a solid waste is considered a RMW if it is capable of producing an infectious disease in humans or if it is not excluded under the regulations. RMW includes:

  • Cultures and stock of microorganisms and biologicals;
  • Human blood and human body fluids;
  • Tissues and other anatomical wastes;
  • Sharps. (needles, syringes, etc.);
  • Animal carcasses, body parts, bedding and related wastes that are known to be infected with human pathogens;
  • Any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill of any RMW; and
  • Any solid waste contaminated by or mixed with RMW.

Managing Regulated Medical Waste (RMW)

Permit Requirements

If you treat, store, or dispose of RMW, you are required to have a permit for the management of RMW, unless exempt under the regulations.

Permit-by-Rule

Facilities that meet the following conditions may be qualified to operate under a permit for RMW management activities and their owners or operators are not required to comply with permit issuance procedures:

  • The facility and all RMW activities are in compliance with all state and local requirements;
  • More than 75% (by weight, in a calendar year) of all RMW that is stored, treated or disposed of by the facility is generated on-site;
  • No RMW is transported from or received by the facility without being properly packaged and labeled. Facilities storing RMW will indicate the first date that the waste was placed in storage date on the outer packaging of the RMW;
  • The activities at the facility do not involve the placing of RMW directly into or on the land;
  • 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 owner or operator of the facility has submitted to the director a certification from the local governing body, without qualifications, conditions, or reservations, that the location and operation of the facility are consistent with all applicable ordinances;
  • The owner or operator of the facility has submitted to the director appropriate Key Personnel Disclosure Statements; and
  • A person certified by the Board of Waste Management Facility Operators will operate the facility.

Packaging and Labeling

Generators of RMW are responsible for the packaging and labeling of the wastes. Once a bag or container becomes full, it must be sealed, labeled and managed in accordance with the regulations. Contractors or other agents may provide services to the generator, including packaging and labeling of RMW, if the packaging or repackaging is performed on-site where the RMW was generated and no transportation, storage, treatment or disposal occurs prior to the packaging or repackaging.

All RMW shall be packaged as follows:

  • When RMWs are discarded, they shall be placed in containers that meet the requirements of the standards for occupational exposure to bloodborne pathogens. 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 RMW. Packaging shall be labeled as required;
  • Contaminated sharps shall be placed directly in containers as required by the general industry standards. The containers shall be labeled as required;
  • As bags and containers become full, they shall be sealed such that no waste materials can leak;
  • Prior to transporting RMW, 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;
  • Waste 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:
    • The name, address and business telephone number of the generator;
    • "RMW" in large print; and
    • The Biological Hazard Symbol.
  • All etiological agents that are transported must be packaged and labeled in accordance with federal and other applicable regulations;
  • 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); and
  • Persons packaging RMW shall wear appropriate items of personal protective equipment

Reusable Containers

RMW may be conveyed in reusable carts or containers under the following conditions:

  • The waste in the cart or container is packaged and labeled fully in accordance with state regulations;
  • 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; and
  • When reusable carts or containers containing RMW are used for off-site transport, all aspects of the cart or container management shall comply with all applicable federal Department of Transportation Hazardous Material Regulations.

Spill Containment and Cleanup Kit

All RMW management facilities are required to keep a spill containment and cleanup kit within the vicinity of any area where RMW is managed. The kit location shall provide for rapid and efficient cleanup of spills anywhere within the area. All vehicles transporting RMWs are required to carry a spill containment and clean up kit whenever RMWs are conveyed.

Containment and Cleanup Procedures

If there is a RMW spill, the following procedures shall be implemented:

  • Take appropriate precautions to ensure personnel do not come into contact with any contaminants by wearing appropriate personal protective equipment;
  • Repackage spilled waste in accordance with required packaging requirements;
  • Transport any regulated medical waste by a registered transporter;
  • Clean and disinfect any areas having been contacted by RMW.
  • Materials used to decontaminate the area will be disinfectants effective against mycobacteria; and 
  • Take necessary steps to replenish containment and cleanup kit.

Treatment and Disposal

  • All regulated medical waste must be incinerated, sterilized by steam, or treated by a method as described in the RMW regulations.
  • No RMW shall be disposed of in a solid waste landfill or other solid waste management facility. Upon authorized treatment and management, the solid waste or its ash is not RMW and may be disposed of at any permitted landfill or other permitted solid waste management facility.
  • 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.

Closure Requirements

When a facility that has been used for RMW management is to cease operations involving regulated medical wastes, it shall be thoroughly cleaned and disinfected. All RMW shall be disposed of, and all equipment decontaminated.

Recordkeeping Requirements

Unless a generator is exempt from recordkeeping requirements, generators and RMW management facilities shall maintain the following accurate records for three years:

  • 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;
  • 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;
  • A notebook or file containing the adopted policies and procedures of the facility for dealing with regulated medical wastes;
  • A log of all special training received by persons involved in regulated medical waste management; and
  • 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.

All RMW management facilities shall maintain the following accurate records:

  • A signed certificate for each load received in which the generator affirms that the load does not contain hazardous waste or radioactive materials; and
  • 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 radioactive materials, except as provided under the regulations.
Transporting Regulated Medical Waste
  • All transporters must be registered with the DEQ prior to transporting any RMW and been issued a registration number.
  • RMW stored for more than seven days must be refrigerated and kept at an ambient temperature between 35 and 45 degrees Fahrenheit. A vehicle that is parked for more than 24 hours during transport will be considered a storage facility.
  • A covered loading area is not required if RMW are in a container that is resistant to the elements
  • Transporters must keep transport vehicles sanitized and decontaminated.

OSHA Regulations HERC OSHA State Page

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  Virginia is one of 21 states operating an approved occupational safety and health program. This program is operated by the Virginia Department of Labor and Industry. OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste

Statutes, Regulations and Guidelines

Contacts

More Information