Permitting
Renew your permit online by creating an account, referencing your billing ID # (BID#) and permit number. If you are unable to create or access your account, you may pay your permit fees by contacting your local county health department.
Apply for a biomedical waste generator permit by completing an Application for Biomedical Waste Generator Permit/Exemption and submit along with the permit fee to the local county health department in the county the business is located, and to discuss if there are any additional local fees for the permit.
There are approximately 50,000 facilities in Florida that generate biomedical waste, including hospitals, clinics, nursing homes, laboratories, funeral homes, dentists, veterinarians, physicians, pharmacies, body piercing and tattoo shops, transporters, and storage and treatment facilities.
The Florida Department of Health (DOH) and the Florida Department of Environmental Protection (DEP) have responsibilities under this program.
- DOH has primary authority and responsibility for facilities that generate, transport, store, or treat biomedical waste through processes other than incineration.
- DEP has primary responsibility for biomedical waste incineration and final disposal.
Permitting Requirements and Florida Laws
Complete the Application for Biomedical Waste Generator Permit/Exemption and submit along with the permit fee to your local county health department in the county the business is located, and to discuss if there are any additional local fees for the permit.
Permit Renewals
Renew your permit online and create an account referencing your billing ID # (BID#) and permit number. If you are unable to create or access your account, you may pay your permit fees by contacting the local county health department.
Florida Laws
The following provides guidance to facilities that generate biomedical waste to aid them in ensuring proper management of that waste, in accordance with section 381.0098, Florida Statutes.
Chapter 64E-16, Florida Administrative Code, includes established parameters for the safe handling and treatment of biomedical waste. Commercial biomedical waste treatment facilities and red bags for biomedical waste containment that meet the rule standards. Other red bags also may be used if they meet or exceed the construction standards required by Chapter 64E-16, F.A.C. The rule also instructs biomedical waste facilities in providing training to personnel whose responsibilities include some aspect of managing biomedical waste. Personnel should receive training prior to assuming any duties associated with biomedical waste and receive an annual refresher course.
- Training details the procedures included in the facility’s written operating plan, as well as compliance with Florida laws.
- Model biomedical waste operating plan can assist facilities in documenting their management procedures.
Many facilities have their biomedical waste removed by a registered biomedical waste transporter.
Frequently Asked Questions
How do I apply for a biomedical waste generator permit?
Complete the Application for Biomedical Waste Generator Permit/Exemption (DH4089).
Submit completed application and permit fee to the local county health department having jurisdiction of the biomedical waste program in the county in which the business resides.
It is also recommended that you contact the local county health department to determine if there are any additional local fees for the permit.
How do I apply for a biomedical waste exemption?
To qualify for a biomedical waste exemption, a permitted facility must show documentation from the previous 12 months showing the actual weight of biomedical waste generated in each 30-day period was less than 25 pounds.
My transporter stated that I can change the frequency of pick-up and I can ask for an exemption. How do I change this?
There is no exemption to change the frequency of your biomedical waste pickup.
Storage of biomedical waste at the generating facility must not exceed 30 days.
The 30-day period will 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.
How do I open a trauma scene cleanup company?
Complete the Application for Biomedical Waste Transporter Registration (DH4106) and Application for Biomedical Waste Generator Permit/Exemption (DH4089).
Submit completed applications, and permit and registration fees to the local Department of Health office having jurisdiction of the biomedical waste program in the county in which the business resides.
What applications do I need to submit to transport biomedical waste from a medical office?
Complete the Application for Biomedical Waste Transporter Registration (DH4106) and Application for Biomedical Waste Storage Permit (DH4107).
Submit completed applications, and permit and registration fees to the local county health department having jurisdiction of the biomedical waste program in the county in which the business resides.
It is also recommended that you contact the local county health department to determine if there are any additional local fees for the permit.
What is the process after I submit an application?
The local county health department will conduct an inspection of your facility to ensure compliance with Florida laws, prior to issuing a permit or registration.
How do I change the facility address?
Complete the Application for Biomedical Waste Generator Permit/Exemption (DH4089). Write “Amended” at the top of the application.
Submit the to the local county health department having jurisdiction of the biomedical waste program in the county in which the facility resides.
- If there was a change in ownership or control, the facility must submit a new application and permit fee.
Is a permit or registration transferrable?
Biomedical waste permits, exemptions, and registrations are not transferable from one ownership to the other.
Also, biomedical waste permits, exemptions, and registrations are not transferable when there is a change in control.
How do I dispose of my personal-use needles that I have at home?
There are several locations in Florida that have needle collection sites to assist residents in safely disposing of needles, syringes with needles, and lancets.
Do you have any guidance for disposal of this biomedical waste if I had an accident or injury in my home?
View guidelines for disposal.
What do I need to transport biomedical waste?
A transport vehicle must meet the requirements of Rule 64E-16.008, F.A.C., including but not limited to:
- Area holding the biomedical waste must be fully enclosed.
- Capable for the containment of outer containers of all sizes.
- Impervious to liquids and prevention of leakage. Vehicles with upholstery or carpeting or exposed crevices are not allowed.
- Floors must be constructed of smooth, easily cleanable materials that are impervious to liquids.
All transport vehicles containing biomedical waste must 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.
How do I treat biomedical waste?
- Biomedical waste must be treated by steam, incineration, or an alternative process approved by the Florida Department of Health as described in Rule 64E-16.007(4), F.A.C., prior to disposal.
- Incineration of biomedical waste is regulated and permitted by the Department of Environmental Protection.
- Treatment shall occur within 30 days of collection from the generator.
How do I open a biomedical waste treatment facility?
A treatment facility must meet the requirements of Rule 64E-16.007, F.A.C., including but not limited to:
- A treatment method utilizing steam, or an alternative process approved by the Florida Department of Health as described in Rule 64E-16.007(4), F.A.C..
- Complete the Application for Biomedical Waste Treatment Permit (DH4111) and Application for Biomedical Waste Storage Permit (DH4107).
- Submit completed application and permit fee to the local county health department having jurisdiction of the biomedical waste program in the county in which the business resides.
- It is also recommended that you contact the local county health department to determine if there are any additional local fees for the permit.
- Achieving successful validation testing
- Achieving a satisfactory inspection by the Florida Department of Health
Treatment processes must be approved in accordance with section 381.0098, F.S., and Rule 64E-16.007, F.A.C.
View Inspection Data
View inspection reports (by county) from the Florida Department of Health for regulated biomedical waste establishments. Approximately 50,000 regulated entities are inspected annually, however some exemptions apply.
Complaints
Complaints concerning biomedical waste is investigated by local county health departments. While small amounts of improperly disposed biomedical waste are cleaned up locally, emergency situations are referred to DEP.
Program Funding
The 1993 Florida Legislature provided funding for the Biomedical Waste Program from the Solid Waste Management Trust Fund. Additional funding is provided through the annual registration of biomedical waste transporters and the annual permitting of storage and treatment facilities plus those generating facilities that produce at least 25 pounds of biomedical waste in any 30-day period of the year.
About 50,000 facilities are inspected annually. However, approximately 13,000 generating facilities that produce less than 25 pounds of biomedical waste in each 30-day period of the year are exempt from from the permit fee, and are inspected once every three years.