Regulated Medical Waste

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.

Medical Waste Definition

"Medical waste” means waste which meets both of the following requirements:

(1) The waste is composed of waste which is generated or produced as a result of any of the following actions:

Diagnosis, treatment, or immunization of human beings or animals.
Research pertaining to the above.
The production or testing of biologicals.
The accumulation of properly contained home-generated sharps waste that is brought by a patient, a member of the patient’s family, or by a person authorized by the enforcement agency, to a point of consolidation approved by the enforcement agency.
Removal of a regulated waste from a trauma scene by a trauma scene waste management practitioner.

(2) The waste is either of the following:

Biohazardous waste.
Sharps waste.

Medical waste does not include any of the following:

Waste generated in food processing or biotechnology that does not contain an infectious agent.
Waste generated in biotechnology that does not contain human blood or blood products or animal blood or blood products suspected of being contaminated with infectious agents known to be communicable to humans.
Urine, feces, saliva, sputum, nasal secretions, sweat, tears, or vomitus, unless it contains fluid blood.
Waste which is not biohazardous, such as paper towels, paper products, articles containing non-fluid blood, and other medical solid waste products commonly found in the facilities of medical waste generators.
Hazardous waste, radioactive waste, or household waste.
Waste generated from normal and legal veterinarian, agricultural, and animal livestock management practices on a farm or ranch.

Large vs. Small Waste Generators

The Medical Waste Management Act (MWMA) considers any person whose act or process produces medical waste to be a “medical waste generator” in California (e.g. a facility or business that generates, and/or stores medical waste onsite). Medical waste generators may be either:

large quantity generators (LQG = >200lbs/month), or
small quantity generators (SQG = <200lbs/month).

Registration

Medical waste generators must register with their enforcement agency (click here for a list of Local Enforcement Agencies ).

Medical waste generators, whether large quantity generators or small quantity generators, located in counties where the state acts as the local enforcement agency (see the CA state map link above to determine the enforcement agency in each county) must complete the Generator Registration Application (see below) and mail it along with the fee page (below) to the address provided. For those medical waste generators treating medical waste on-site, an on-site treatment permit application must also be completed and submitted. Each application, along with a check made payable to the Medical Waste Management Fund must be mailed to:

California Department of Health Services
Medical Waste Management Program
P.O. Box 997413, MS 7405
Sacramento, CA 95899-7413

DHS form # 8550 Generator Registration Application
DHS form # 8662 Current Fees
DHS form # 8667--Medical Waste Facility Permit Application

Management Plan

LQG's or SQG with on-site treatment are required to submit a Medical Waste Management Plan (Plan) with their medical waste enforcement agency. A Plan Checklist is provided to assist medical waste generators in developing their Plan.

DHS form #8661 Medical Waste Management Plan Checklist

Segregation and Storage

Rules for containerizing and storing medical waste vary depending or the type of waste. The following rules apply (for complete rules see Chapter 9 of the Medical Waste Management Act, below):

Medical waste must be contained separately from other waste at the point of origin in the healthcare facility. Sharps containers may be placed in biohazard bags or in containers with biohazard bags.
Biohazardous waste must be placed in a red biohazard bag conspicuously labeled with the words “Biohazardous Waste” or with the international biohazard symbol and the word “BIOHAZARD.”
Sharps waste must be contained in a sharps container.
Biohazardous waste that is contaminated through contact with, or having previously contained, chemo-therapeutic agents, must be segregated for storage, and, when placed in a secondary container, that container must be labeled with the words “Chemotherapy Waste”, “CHEMO”, or other label approved by the department on the lid and on the sides, so as to be visible from any lateral direction.
Biohazardous waste comprised of human surgery specimens or tissues which have been fixed in formaldehyde or other fixatives, must be segregated for storage and, when placed in a secondary container, that container must be labeled with the words “Pathology Waste”, “ PATH”, or other label approved by the department on the lid and on the sides, so as to be visible from any lateral direction.

To containerize biohazard bags, a person must do all of the following:

The bags must be tied to prevent leakage or expulsion of contents during all future storage, handling, or transport.
Biohazardous waste must be appropriately bagged and placed for storage, handling, or transport in a rigid container which may be disposable, reusable, or recyclable.
Containers must be leak resistant, have tight-fitting covers, and be kept clean and in good repair.
Containers may be of any color and 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 so as to be visible from any lateral direction.
Biohazardous waste must not be removed from the biohazard bag until treatment is completed.
Biohazardous waste must not be disposed of before being treated.
If a facility generates 20 or more pounds of biohazardous waste per month, the facility must not contain or store biohazardous or sharps waste above 0 degrees Centigrade (32 degrees Fahrenheit) at any onsite location for more than seven days without obtaining prior written approval of the enforcement agency.
If a facility generates less than 20 pounds of biohazardous waste per month, the person must not contain or store biohazardous waste above 0 degrees Centigrade (32 degrees Fahrenheit) at any onsite location for more than 30 days.
A facility may store biohazardous or sharps waste at or below 0 degrees Centigrade (32 degrees Fahrenheit) at an onsite location for not more than 90 days without obtaining prior written approval of the enforcement agency.
A facility may store biohazardous or sharps waste at a permitted transfer station at or below 0 degrees Centigrade (32 degrees Fahrenheit) for not more than 30 days without obtaining prior written approval of the enforcement agency.
A facility must not store biohazardous or sharps waste above 0 degrees Centigrade (32 degrees Fahrenheit) at any location or facility which is offsite from the generator for more than seven days before treatment.

To containerize sharps waste, a facility must do all of the following:

Place all sharps waste into a sharps container.
Tape closed or tightly lid full sharps containers ready for disposal to preclude loss of contents.
Store sharps containers ready for disposal for not more than seven days.
Label sharps containers with the words “sharps waste” or with the international biohazard symbol and the word “BIOHAZARD”.

Treatment of Medical Waste

A person generating or treating medical waste shall ensure that the medical waste is treated by one of the following methods, thereby rendering it solid waste prior to disposal:

Incineration at a permitted medical waste treatment facility in a controlled-air, multi-chamber incinerator, or other method of incineration approved by the department which provides complete combustion of the waste into carbonized or mineralized ash.
Treatment with an approved alternative technology that, due to the extremely high temperatures of treatment in excess of 1300 degrees Fahrenheit, has received express approval from the department.
Steam sterilization at a permitted medical waste treatment facility or by other sterilization, in accordance with all approved operating procedures for steam sterilizers or other sterilization
Other alternative medical waste treatment methods which are approved by the department and result in the destruction of pathogenic micro-organisms.

Disposal of Medical Waste

A medical waste may be discharged to a public sewage system without treatment if it is not a biohazardous waste, it is liquid or semiliquid, and its discharge is consistent with waste discharge requirements placed on the public sewage system by the California regional water quality control board with jurisdiction.
A medical waste that is a biohazardous waste may be treated by a chemical disinfection if the medical waste is liquid or semi-liquid and the chemical disinfection method is recognized by the National Institutes of Health, the Centers for Disease Control and Prevention, or the American Biological Safety Association, and if the use of chemical disinfection as a treatment method is identified in the site’s medical waste management plan. If the waste is not treated by chemical disinfection, it shall treated by one of the other approved methods. Following treatment by chemical disinfection, medical waste may be discharged to the public sewage system if the discharge is consistent with waste discharge requirements placed on the public sewage system by the California regional water control board, and the discharge is in compliance with the requirements imposed by the owner or operator of the public sewage system. If the chemical disinfection of the medical waste causes the waste to become a hazardous waste, the waste shall be managed in accordance with applicable requirements
Recognizable human anatomical parts, with the exception of teeth not deemed infectious by the attending physician and surgeon or dentist, shall be disposed of by interment or in accordance with the regulations, unless otherwise hazardous.
Sharps waste shall be rendered noninfectious prior to disposal by Incineration; steam sterilization; or disinfection, using an alternative treatment method approved by the department. Sharps waste rendered noninfectious may be disposed of as solid waste if the waste is not otherwise hazardous.
Onsite medical waste treatment facilities treating sharps waste shall ensure that, prior to disposal, the treated sharps waste is destroyed or that public access to the treated sharps waste is prevented.
An operator of a permitted hazardous waste incinerator may also accept medical waste for incineration.
Each medical waste treatment facility issued a medical waste permit shall provide the enforcement agency with an emergency action plan that the facility shall follow to ensure the proper disposal of medical waste in the event of equipment breakdowns, natural disasters, or other occurrences.
Animals that die from infectious diseases shall be treated in accordance with the regulations, if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans.

Waste Tracking Documents

Tracking documents are provided to the generator by the transporter. Medical waste generators are required to maintain a completed tracking document of all medical waste removed for treatment or disposal for a period of three years.

Contacts

Inquiries to the Medical Waste Management Program may be sent via e-mail to: MedWasteInfo@dhs.ca.gov.

For more information on Medical Waste Management Program activities contact either the Medical Waste Management Program HQ at (916) 449-5671, or the Southern California Regional Office at (213) 977-7379 or (213) 977-6877.

OSHA Regulations

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. California is one of 24 states operating an approved occupational safety and health program. This program is operated by Cal/OSHA. 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.

Regulations

The Medical Waste Management Act (MWMA) governs the management of medical waste in all jurisdictions of the State.

Additional Resources

Medical waste generator information.