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Biomedical Waste Florida Guidelines Back to Course Index





Florida Chapter 64E-16 prescribes minimum sanitary practices for managing biomedical waste, including segregation, handling, labeling, storage, transport, and treatment.  This chapter applies to all facilities that generate, transport, store, or treat biomedical waste to ensure that the waste is handled correctly to protect public health.  Further, this chapter prescribes minimum standards for permitting biomedical waste generators, storage facilities, and treatment facilities and registering biomedical waste transporters.  

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

When biomedical waste is improperly managed, healthcare workers, sanitation workers, and the general public are at an increased risk of contracting dangerous diseases.  Many facilities have their biomedical waste removed by a registered biomedical waste transporter.

You need to have an understanding of the handling of healthcare waste, including biohazard waste, chemical waste, chemotherapy waste, pathological waste, and others, if you’re in the Florida healthcare industry.  Based on federal regulations (Resource Conservation and Recovery Act – RCRA), storing, treating, or disposing medical waste without a permit can cost you $50,000 per day for a single violation.  Endangering the public through the treatment, transportation, storage, or disposal of hazardous waste can cost you $250,000 and up to $1 million if you’re an organization.  It’s vital to understand Florida’s medical waste regulations to avoid fines like these. 

In addition to the pain of fines, there are several other reasons to manage biomedical waste appropriately:

  • Health – Nobody wants to see blood drops on the floor when they walk into a healthcare setting.   
  • Infection risk – the risk of infection obtained from sharp injuries can lead to infection.
  • Environment pollution – The risk of air, water, and soil pollution directly from waste due to defective incineration or autoclaving can be harmful.

Biomedical waste treatment and disposal should be a complete process to ensure the workplace’s safety and to maintain health.  If you maintain the safety process correctly, it will:

  • Effectively reduce your legal liability
  • Reduce the danger to the community, personnel, and clients or patients
  • Maintain your facility’s reputation

Other federal and state agencies are involved in biohazard waste regulations from Florida, such as the Occupational Safety and Health Administration (OSHA).  Primarily, OSHA is focused on the Occupational Exposure to Blood-Borne Pathogens Standard, which influences the handling of medical or infectious waste, including sharps management, specific requirements for sharps container placement and usage, and employee training.


Definition and Identification of Biomedical Waste

Biomedical waste is defined as “any solid or liquid waste which may present a threat of infection to humans, non-liquid 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.”

Healthcare activities generate waste from used needles and syringes to soiled dressings, body parts, diagnostic samples, blood, chemicals, pharmaceuticals, medical devices, and radioactive materials.  

Different medical waste stream categories require different segregation, storage, and transportation approaches. 

Biomedical waste is separated into seven different categories.


Blood Products:
Human blood, blood products, and any body fluids 

Waste is covered with human blood, body fluids, or other blood products.

Pathological Waste:
Human pathological waste, including tissues, anatomical parts, and any other parts that might have been discarded during surgery

Sharp needles are used in human or animal care/research labs.

Infectious Agents:
Culture dishes and infectious agents from DNA research

Discarded carcasses, including bedding, body parts, and other waste materials, are designed for research facilities only and, therefore, only contain pathogenic waste hazardous to humans or the natural environment.

Cytotoxic drugs that are listed under chapter x50 of the Environmental Productions list






You can’t store biomedical waste from a generating facility for more than 30 days in Florida?  (64E-16.004) That 30-day period starts when a non-sharp biomedical waste item is tossed into a sharps container or a red bag or when a sharps container is sealed.

Containment is a critical factor in safe storage and handling.  Florida is particular about its medical waste, including red bags.  Red bags must meet or exceed the requirements of the state of Florida’s Administrative Code (Chapter 64E-16). 

Sharps injury reduction and reduction of needlestick injuries are the goals for sharps container placement, sharps removal service options, and employee safety. 

Found under 64E-16.004, the state of Florida mandates that a permanently mounted sharps container holder must be clearly labeled with the phrase and the international biological hazards symbol described in paragraph 64E-16.004(2)(a), F.A.C.; if the sharps container holder conceals this information on the sharps container.

Biological hazards symbols must be at least 6 inches in diameter on outer containers that are 19″ x 14″ or larger and at least 1 inch in diameter on outer containers that are less than 19″ x 14″.

Sharps will be placed into sharps containers at the point of origin.

Filled red bags and filled sharps containers will be sealed at the point of origin.  When sealed, red bags, sharps containers, and outer containers of biomedical waste should not be reopened.  Ruptured or leaking packages of biomedical waste should be placed into a larger container without disturbing the original seal.



All sealed biomedical waste red bags and sharps containers should be labeled with the facility’s name and address before offsite transport.  If a sealed red bag or sharps container is placed into a larger red bag prior to transport, placing the facility’s name and address only on the exterior bag is sufficient.

Outer containers must be labeled with our transporter’s name, address, registration number, and 24-hour phone number.



If contracting out the transport of biomedical waste, only use a DOH-registered company.  Pickup receipts should be maintained for the last three (3) years.  If you choose to transport your biomedical waste, you should maintain a log of all biomedical waste transported by any employee
for the last three (3) years.  The log will contain waste amounts, dates, and documentation that the waste was accepted by a permitted facility. 




Contingency Plan for Emergency Transport

In the event that your transporter cannot transport the facility’s biomedical waste.  or if you are unable temporarily to treat your waste, then you should utilize a contingency plan that you put in place in advance of such an obstacle.  This could include a second transporter.


Don’t underestimate biomedical waste concerns.

It is estimated that just over 40,000 facilities in the state of Florida generate biomedical waste, including but not limited to:

  • hospitals
  • nursing homes
  • clinics
  • dentists
  • funeral homes
  • laboratories
  • tattoo/body piercing shops

Taking the time to read through governing regulations aids any size facility or waste generator in maintaining and observing compliance with regulations.  Medical waste generators are responsible for proper medical waste disposal and regarding what type of waste stream is generated.  It’s also the generator’s responsibility to ensure that any medical sharps disposal companies, medical waste pickup companies, or sharps removal services follow state and federal guidelines.


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