Do I Need a Biomedical Waste Permit for my Clinic?

Biomedical Waste Permit Regulations

Biomedical waste is the inevitable outcome in most health care offices. Professionals in the health care field need to keep up to date information on the regulations for handling any type of biomedical or hazardous/chemical waste that is a result of services provided. While the most obvious concerns are those of public safety and possible health risks, if not stored or disposed of properly, this waste can also result in thousands of dollars in fines.  There are many types of health care waste to consider: biohazard, chemical, pathological, chemotherapy waste, etc. The waste produced by each office will determine the proper treatment and disposal. The Department of Health along with the state’s environmental and health departments regulate the storage, containment, treatment, and disposal of biomedical waste.

What is Biomedical Waste?

According to the State of Florida’s Bureau of Community Environmental Health, Biomedical waste is defined as any solid or liquid waste that may present a threat of infection to humans. The term includes, but is not limited to, nonliquid human tissue and body parts; laboratory and veterinary waste that contains human-disease-causing agents; discarded disposable sharps; human blood and human blood products and body fluids; and other materials that in the opinion of the Department of Health represent a significant risk of infection to persons outside the generating facility. The term does not include human remains that are disposed of by persons licensed under Chapter 497.

Biomedical Waste Storage and Containment

In Florida, biomedical waste generated from a facility cannot be stored for more than 30 days. The period of allowable storage begins from the moment a non-sharp article of biomedical waste is thrown into a red bag or a sharps container or when a sharps container is sealed. All containers, bags, or packages of waste must be clearly identifiable with the international biomedical waste symbol. All contained waste must remain sealed until treatment occurs. If a container should be ruptured, the original package must be placed into a new container without disrupting the original packaging. Any indoor storage area for biomedical waste must have restricted access and be described in the operating plan.  Outdoor storage areas must be clearly identifiable with the international biomedical waste symbol and have some form of security or protection against theft or vandalism. All symbols must be red, orange, or black and have a contrasting background color. All symbols must be a minimum of 6 inches in diameter.

Disposal of Biomedical Waste

Packages that are compacted should be incinerated or treated via approved treatment process. Other treatments must be approved via written request by the Department of Health. There are various treatment options available: treatments by gas, steam, chemical, dry temperatures, or microwaving are all approved and available. Waste may be disposed by transporting to a sanitary sewer system, an onsite sewage treatment disposal system. The disposal systems must be approved by the Department of Environmental Protection or the Department of Health.


All facilities housing biomedical waste shall obtain an annual permit from the Department of Health. The form DH 4089, Application for Biomedical Waste Generator Permit/Exemption and the corresponding fees should be submitted to the local Department of Health facility. This permit needs to be renewed annually no later than September 30th of every year. If any facility eliminates less than 25 lbs of biomedical waste within a 30 day period, it is exempt from having to obtain permits and fee requirements. To qualify for exemption, documentation proving the weight of the waste generated for a 30 day period must be provided. After applications are submitted, the Department of Health will conduct an inspection of the facility to ensure compliance with section 381.0098 of the Florida Statutes. After inspection, the Department will notify if the facility is eligible to receive exemption.

Sharps Storage, Containment and Disposal

A permanently mounted sharps container is mandated by the state of Florida for businesses that use and dispose of needles. It must be labeled with the approved phrases of the international biomedical waste regulations. Containers must always be readily available and as close to the location of use as possible. The container should be disposed of once ¾ full to avoid any potentially dangerous contamination.


It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.


All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Jamaal Jones


This post was authored by Jamaal R. Jones, Esquire (Partner) of Jones Health Law, P.A. where we provide "On-Call Legal Services to Healthcare Professionals". For more information contact us at (305) 877-5054; email us at JRJ@JonesHealthLaw.com, or visit our website at www.JonesHealthLaw.com

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