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Biomedical Waste

Background Information
Definition of Regulated Medical Waste
Managing Regulated Medical Waste
OSHA Regulations
Statutes, Regulations and Guidelines
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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 Biomedical Waste

Biomedical waste is any solid or liquid waste which may present a threat of infection to humans, including nonliquid tissue, body parts, blood, blood products, and body fluids from humans and other primates; laboratory and veterinary wastes which contain human disease-causing agents; and discarded sharps. The following are also included:

  • Used, absorbent materials saturated with blood, blood products, body fluids, or excretions or secretions contaminated with visible blood; and absorbent materials saturated with blood or blood products that have dried; and
  • Non-absorbent, disposable devices that have been contaminated with blood, body fluids or, secretions or excretions visibly contaminated with blood, but have not been treated by an approved method.

Managing Biomedical Waste

The Florida Department of Health (the Department) has primary authority and responsibility for facilities that generate, transport, store, or treat biomedical waste through processes other than incineration. The Florida Department of Environmental Protection (DEP) has primary responsibility for biomedical waste incineration and final disposal.  

All biomedical waste facilities shall comply with the following:

  • Biomedical waste mixed with hazardous waste shall be managed as hazardous waste.
  • Biomedical waste mixed with radioactive waste shall be managed in a manner that does not violate the provisions of and in accordance with radiation control regulations and packaging requirements.
  • Any other solid waste or liquid, which is neither hazardous nor radioactive in character, combined with untreated biomedical waste, shall be managed as untreated biomedical waste.
  • All surfaces contaminated with spilled or leaked biomedical waste shall be decontaminated as part of the cleaning process.

Each biomedical waste facility shall implement a written operating plan to manage biomedical waste, and contain specific components as required by the regulations. The plan shall be available for review by the department and facility personnel.

Generator Requirements

Biomedical waste generators shall not negotiate for the transport of biomedical waste with a person who is not registered with the department as a biomedical waste transporter.

Compacting packages of biomedical waste within the generating facility, except recognizable human tissue, bulk liquids, or sharps, is acceptable provided the following conditions are met::

  • Packages of biomedical waste shall not be compacted to a density greater than 22 pounds per cubic foot;
  • Compacted packages of biomedical waste shall not be subjected to further compacting;
  • Any residual or incidental liquid shall be contained within the inner bag or outer container. Should the inner bag or outer container rupture during compaction, residual or incidental liquids shall be disposed of directly into the sanitary sewer, an on-site sewage treatment and disposal system, or other system approved to receive such wastes by the DEP or the department;
  • Discharge of noxious air shall be kept to a minimum through use of HEPA filters having a pore size of 2 microns or less, negative pressure rooms, or other safety methods; and
  • Compacted packages of biomedical waste shall be treated by incineration or other approved treatment process.


All biomedical waste facilities, except those facilities operating under a DEP permit, shall obtain an annual permit (there is a permit fee) from the department. This includes biomedical waste generators, storage facilities, treatment facilities, and waste sharps collection programs.

Storage Requirements

  • Storage of biomedical waste at the generating facility shall not exceed 30 days. The 30-day period shall commence when the first non-sharps item of biomedical waste is placed into a red bag or sharps container, or when a sharps container containing only sharps is sealed.
  • Storage of biomedical waste in a place other than at the generating facility shall not exceed 30 days. The 30-day storage period shall begin on the day the waste is collected from the generator.
  • Indoor storage areas shall have restricted access and be designated in the written operating plan. They shall be located away from pedestrian traffic, be vermin and insect free, and shall be maintained in a sanitary condition. They shall be constructed of smooth, easily cleanable materials that are impervious to liquids.
  • Outdoor storage areas, including containers and trailers, shall, in addition to the above criteria, be conspicuously marked with the international biological hazard symbol and be secured against vandalism and unauthorized entry. The international biological hazard symbol on an outdoor storage area shall be a minimum of six inches in diameter.

Containment Requirements

Packages of biomedical waste shall remain sealed until treatment, except when compacted in accordance with biomedical regulations. Ruptured or leaking packages of biomedical waste shall be placed into larger packaging without disturbing the original seal.

All packages containing biomedical waste shall be visibly identifiable with the international biological hazard symbol and one of the following phrases: “BIOMEDICAL WASTE”, “BIOHAZARDOUS WASTE”, “BIOHAZARD”, “INFECTIOUS WASTE”, or “INFECTIOUS SUBSTANCE”. The symbol shall be red, orange, or black and the background color shall contrast with that of the symbol or comply with the federal requirements

Biomedical waste, except sharps, shall be packaged and sealed at the point of origin in impermeable, red plastic bags or, at the discretion of the generator, into sharps containers. The international biological hazard symbol shall be at least six inches in diameter on bags 19´´ × 14´´ or larger, and at least one inch in diameter on bags smaller than 19´´ × 14´´. Each plastic bag shall meet the following physical properties:

  • Impact resistance of 165 grams and tearing resistance of 480 grams in both the parallel and perpendicular planes with respect to the length of the bag. Impact resistance shall be determined using ASTM D-1709-91, and tearing resistance shall be determined using ASTM D-1922-89.
  • Incidental sum concentrations of lead, mercury, hexavalent chromium and cadmium shall be no greater than 100 ppm for dyes used in the coloration of bags.

Sharps shall be discarded at the point of origin into single use or reusable sharps containers. Needles and scalpel blades shall not be placed directly into double-walled corrugated containers. Sharps containers must be sealed when full. A sharps container is considered full when materials placed into it reach the designated fill line, or, if a fill line is not indicated, when additional materials

cannot be placed into the container without cramming or when no additional materials are to be placed in the container. Other requirements for sharps include:

  • Permanently mounted sharps container holders shall bear the phrase and the international biological hazard symbol if this information on the sharps container is concealed by the sharps container holder;
  • Reusable sharps containers shall only be emptied into a treatment cart or directly into a treatment unit. They shall be constructed of smooth, easily cleanable materials, and shall be decontaminated after each use;
  • The international biological hazard symbol shall be at least one inch in diameter on sharps containers;
  • All outer containers shall be rigid, leak-resistant and puncture-resistant. Reusable outer containers shall be constructed of smooth, easily cleanable materials and shall be decontaminated after each use; and
  • The international biological hazard symbol shall be at least six inches in diameter on outer containers 19´´ x 14´´ or larger, and at least one inch in diameter on outer containers less than 19´´ x 14´´.

Labeling and Marking Requirements

Generator Labeling Requirements. Biomedical waste bags and sharps containers shall be labeled with the generator's name and address unless treatment occurs at the generating facility. If a bag or sharps container is placed into a larger bag prior to transport, the label for the exterior bag shall comply with biomedical labeling regulations. Inner bags and inner sharps containers are exempt from the labeling requirements

Transporter Labeling Requirements. Outer containers shall be labeled with the transporter's name, address, registration number, and 24-hour telephone number prior to transport. The transporter may provide labels for bags or sharps containers that are generator-specific, such as bar codes or specific container numbers.

Treatment and/or Destruction of Biomedical Waste

  • Biomedical waste shall be treated by steam, incineration, or an alternative process approved by the department, prior to disposal. Treatment shall occur within 30 days of collection from the generator.
  • Steam treatment units shall subject loads of biomedical waste to sufficient temperature, pressure, and time to demonstrate a minimum Log 4 kill of Bacillus stearothermophilus spores placed at the center of the waste load. Additional  operating requirements apply.
  • Incineration of biomedical waste shall be achieved in a biological waste incinerator permitted by the DEP.
  • An alternative treatment process, such as chemical, gas, dry heat, or microwave shredding, shall be considered by the department upon receipt of a written request.
  • Biomedical waste may be disposed into a sanitary sewer system, an onsite sewage treatment and disposal system, or other system approved to receive such waste by the DEP or the department, if it is in a liquid or semi-solid form and aerosol formation is minimal.
  • Body tissues that have been histologically fixed are considered treated biomedical waste. Tissues prepared by frozen sectioning only are not considered treated.
  • Acute care hospitals, which utilize a certified onsite treatment process involving grinding and treatment, may dispose of such treated biomedical waste in the normal municipal solid waste stream upon notifying the local government responsible for solid waste collection, under certain conditions.

Transporting Biomedical Waste

No registered transporter may knowingly accept biomedical waste for transport unless it has been properly segregated, packaged, and labeled.

Each registered transporter shall provide the generator with a receipt of pick-up

During transport, no registered transporter shall compact biomedical waste

Transfer of biomedical waste from one transport vehicle to another is not allowed unless the transfer occurs at a permitted storage or treatment facility, except as provided in the regulations. Intermodal transfers of biomedical waste are allowed provided transport shipping seals remain intact.

Any registered transporter who unknowingly fails to comply with this section because such biomedical waste has not been properly segregated or separated from other solid wastes by the generating facility is not guilty of a violation under this rule.

No registered transporter shall knowingly deliver biomedical waste for storage or treatment to a facility that does not have a valid permit issued by the department.

All transport vehicles containing biomedical waste shall be visibly identified with the business name, registration number, a 24-hour telephone number, and placards showing the phrase and the international biological hazard symbol. The symbol shall be at least six inches in diameter.

All transport vehicles containing biomedical waste shall be fully enclosed and secured when unattended.

Registered transporters shall notify the department within one working day by telephone and shall submit a follow-up report to the department within 10 days, in writing, if there is an accident that results in a spill of biomedical waste.

In case of an emergency situation, including mechanical failure, the following is allowed:

  • If the emergency occurs during transport, biomedical waste may be transferred to another transport vehicle, including a rental vehicle, without being at a storage or treatment facility.
  • If a rental vehicle is used, the department shall be notified of its use on the first working day after the emergency. A copy of the written authorization from the rental agency stating awareness of the intended use of the vehicle shall be submitted to the department within seven days.
  • Biomedical waste shall be removed and transported to a permitted storage or treatment facility within 24 hours of the emergency.
  • Before return to the rental agency, the vehicle shall be decontaminated.

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.  Florida is one of 26 states covered entirely by the federal OSHA program. This program is operated by the Occupational Safety and Health Administration. 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.

Statutes, Regulations and Guidelines

Biomedical Waste Regulations (Chapter 64E-16, Florida Administrative Code)


Florida Department of Health - Biomedical Waste Website

Florida Department of Environmental Protection

Statewide Biomedical Waste Coordinators

For general questions concerning biomedical waste, contact Edith Coulter or Ed Golding, of the Florida Bureau of Community Environmental Health, or by telephone at 850-245-4277.

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