Medical Waste Frequently Asked Questions

What is regulated medical waste?

Regulated medical waste is waste that meets both of the following requirements:

1. The waste is either biohazardous or sharps waste.

Biohazardous waste includes items such as fluid blood or fluid blood products, infectious secretions, laboratory waste, microbiology specimens, surgery specimens, animal parts or animal fluids contaminated with infectious agents known to be contagious to humans.
Sharps waste includes items such as hypodermic needles, syringes, blades and needles with attached tubing, broken glass items, syringes contaminated with biohazardous waste, acupuncture needles, root canal files, or any other device capable of cutting or piercing.

2. The waste is produced as a result of one or more of the following actions:

The diagnosis, treatment, or immunization of human beings or animals.
Research pertaining to the activities specified above.
The production and testing of biological agents.
Accumulated home-generated sharps waste at an approved point of consolidation.
Removal of regulated waste from a trauma scene by a trauma scene waste management practitioner.

Who generates medical waste?

A medical waste generator is typically a person or business involved in the following activities:

The diagnosis, treatment, or immunization of human beings or animals.
Research pertaining to the activities specified above.
The production and testing of biological agents.

The following are examples of businesses considered to be generators of medical waste:

Medical and dental offices
Clinics
Hospitals
Surgery centers
Laboratories/research laboratories
Unlicensed and licensed health facilities
Chronic dialysis clinics
Education and research facilities
Veterinary offices
Clinics and hospitals
Pet shops
Trauma scene waste management practitioners

What are generators required to do?

Submit a Medical Waste Management Plan provided by the Sonoma County Department of Health Services (DHS). It must be renewed when any information changes.
Submit the applicable registration and/or permit fees on an annual basis to DHS.
Obtain medical waste permits and/or registration from DHS.
Participate in annual inspections by DHS when necessary.
Maintain tracking documents and other required records if medical waste is treated on-site.
Comply with the Medical Waste Management Act.

Which permit or registration is required?

A Small Quantity Generator registration is required for businesses that generate less than 200 pounds of medical waste per month.

A Large Quantity Generator permit is required for businesses that generate more than 200 pounds of medical waste per month in any month of a 12-month period.

A Treatment permit is required for businesses that treat (sterilize) medical waste on-site.

A Common Storage permit is required when a business designates an accumulation site for medical waste used by small quantity generators otherwise operated independently and for the storage of such waste for collection by a registered hazardous waste hauler.

A Limited Quantity Hauling Exemption permit is required for any small quantity generator who wishes to transport his/her own medical waste to a permitted transfer station or common storage facility. The generator must generate no more than 20 pounds of waste per week and may not transport more than 20 pounds of waste at any one time.

A Home-Generated Sharps Consolidation Point permit is required for those facilities that wish to accept and consolidate home-generated sharps waste.

How is medical waste to be stored?

Medical waste shall be contained separately from other waste at the point of origin.

All biohazardous waste must be placed in a red bag labeled with the words "Biohazardous Waste" or with the international biohazard symbol and the word "BIOHAZARD." This red bag must be placed in a rigid and leak-resistant container with a tight-fitting lid for storage, handling or transport. This secondary container must be labeled with the words "Biohazardous Waste" or with the international biohazard symbol and the word "BIOHAZARD" on the lid and on the sides in order to be visible from any lateral direction.

All sharps waste must be placed into a sharps container that is rigid, puncture-resistant, leak- resistant when sealed, and difficult to reopen once sealed. The sharps contained must be labeled with the words "SHARPS WASTE" or with the international biohazard symbol and the word "BIOHAZARD." Sharps containers may be placed in red biohazard bags or in rigid containers with biohazard bags.

Waste such as gloves, disposable gowns, towels, intravenous solution bags and attached tubing which are empty and considered biohazardous waste through contact with, or having previously contained chemotherapeutic agents, must be placed in a secondary container labeled with the words "CHEMOTHERAPY WASTE" or "CHEMO."

Biohazardous waste, which is recognizable human anatomical parts or comprised of human surgery specimens or tissues which have been fixed in formaldehyde or other fixatives, must be placed in a secondary container labeled with the words "PATHOLOGY WASTE" or "PATH."

Pharmaceutical waste that is either prescription, over-the-counter, or a veterinary drug may be considered biohazardous waste by definition and must be placed in a container labeled with the words "INCINERATION ONLY." This does not include pharmaceuticals that are listed or defined as hazardous under RCRA or the Radiation Control Law. These pharmaceuticals are regulated under the federal Resource Conservation and Recovery Act of 1976 or the Radiation Control Law (Chapter 8, Part 9). In addition, pharmaceuticals that were not previously hazardous under the California Hazardous Waste Control Law will continue to be regulated as solid waste and may therefore be disposed of in the garbage. In summary, pharmaceutical waste fall into one of three categories based upon their toxicity: hazardous waste, medical waste, or solid waste.

Any area designated for the accumulation and storage of medical waste containers must be secured to prevent entry by unauthorized persons. The exterior door, gate, or lid must be marked with a warning sign in both English and Spanish and any other appropriate languages. The wording shall read "Caution-Biohazardous Waste Storage AreaUnauthorized Persons Keep Out," and in Spanish "Cuidado-Zona De Residous-Biologicos Peligrosos-Prohibida La Entrada A Personas No Autorizadas."

How long may medical waste be stored?

Biohazardous waste may not be stored for more than seven days unless the business generates less than 20 pounds per month. In this case, the waste may be stored up to 30 days. However, if the biohazardous waste is stored at or below 0 degrees centigrade (32 degrees Fahrenheit), it may be stored up to 90 days with approval from DHS.

Full sharps containers ready for disposal may not be stored for more than 30 days.

Pharmaceutical waste containers that are full and ready for disposal may not be stored longer than 90 days. Whether full or not, the container may not remain on site for more than a year.

How do I dispose of medical waste?

The majority of waste is transported to an off-site medical waste treatment facility by a registered hazardous waste hauler or via the postal service using a mail-back system where it is sterilized prior to disposal in a landfill. Some generators transport their own waste to a common storage facility while others may choose to treat their waste on-site prior to disposal.

If untreated medical waste is picked up at the generators business by a registered hazardous waste hauler, insure that, at the time of pickup, the hauler provides a copy of the tracking document. Small quantity generators are required to keep tracking documents for two years and large quantity generators for three years.

Only businesses that generate less than 20 pounds of medical waste per week may opt to transport their own waste. A Limited Quantity Hauling Exemption Permit must be approved and obtained by DHS prior to transporting any waste. No more than 20 pounds of medical waste may be transported at any one time. Only the generator or member of his/her staff may transport the waste. A tracking document must be in the drivers possession while transporting waste and the original tracking document must be provided to the receiving facility (permitted medical waste treatment facility, consolidation point, transfer station, parent organization).

Sharps waste may not be disposed anywhere in Sonoma County whether it has been treated or not. Therefore, all sharps waste must be transported out of Sonoma County for treatment and disposal.

Those generators wishing to treat their own medical waste on-site must be approved for and obtain a treatment permit from DHS. Treatment must be done using an approved method, the most common of which is steam sterilization. Those using steam sterilization must establish written operating procedures, check the thermometer during each cycle to verify an attainment of 121degrees centigrade (250 degrees Fahrenheit) for at least 30 minutes, test the thermometer for calibration annually, use indicator heat-sensitive tape on each biohazard bag and sharps container, and conduct monthly biological indicator tests on the autoclave. Records of these procedures noted above must be kept for three years. Once medical waste is treated, it ceases to be regulated under the Medical Waste Management Act and is considered solid waste.

Where can I get more information?

Please feel free to contact DHS at (707) 565-6565 to request more information or if you have any questions regarding the Medical Waste Management Act and how it might apply to your business.

The California Department of Public Health Services Medical Waste Management Program website also has helpful information and tools.