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Biomedical Waste Program
*Note: This page contains materials in the Portable Document Format (PDF). The free Adobe Reader may be required to view these files.
There are approximately 42,000 facilities in Florida that generate biomedical waste. These include hospitals, clinics, nursing homes, laboratories, funeral homes, dentists, veterinarians, physicians, pharmacies that provide flu shots, body piercing salons, tattoo shops, transporters, and storage and treatment facilities. The objective of the biomedical waste program is to protect health care workers, environmental health staff, biomedical waste transporters, and the general public from risks associated with potentially infectious biomedical waste.
Both the Department of Health and the Florida Department of Environmental Protection (DEP) have responsibilities under this program. The Department of Environmental Protection has primary responsibility for biomedical waste incineration and final disposal. The 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, it places health care workers, sanitation workers, and the general public at risk for contracting dangerous diseases. Section 381.0098, Florida Statutes and Chapter 64E-16, Florida Administrative Code (FAC)(60kb PDF) , provides guidance to facilities that generate biomedical waste to aid them in ensuring proper management of that waste. A model biomedical waste operating plan (38kb PDF) is available to assist facilities in documenting their procedures for management of biomedical waste. Many facilities have their biomedical waste removed by a registered biomedical waste transporter.
Biomedical waste generated by individuals in their own homes from use of syringes or diagnostic lancets also should be properly managed. Many homeowners can find assistance through a local county needle collection program. Where biomedical waste is produced in a home through injury or other major traumatic conditions, the guidelines for home cleanup of biomedical waste (40KB PDF) provide guidance for proper cleanup or trauma scene clean up providers can be contacted to manage site decontamination.
Complaints concerning biomedical waste are investigated by County Health Departments. Small amounts of improperly disposed biomedical waste are cleaned up under Department of Health supervision. Emergency situations are referred to the Department of Environmental Protection, Bureau of Emergency Response, at (850) 245-2010.
The Department maintains inspection data for Biomedical Waste establishments.Quick Links
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 30,000 such facilities are inspected annually. However, the approximately 12,000 generating facilities that produce less than 25 pounds of biomedical waste in each 30-day period of the year are exempt from permitting and from the permit fee, and are inspected once every three years.
Guidance from the Department of Health relative to biomedical waste management assists facilities in ensuring proper identification, segregation, containment, storage, and labeling of biomedical waste. The department has established parameters for the safe handling and treatment of biomedical waste in Chapter 64E-16, Florida Administrative Code (60kb PDF). The department also has produced lists of commercial biomedical waste treatment facilities and of red bags for biomedical waste containment that meet the standards of Chapter 64E-16, Florida Administrative Code. Other red bags also may be used if they meet the construction standards required by Chapter 64E-16, Florida Administrative Code.
Chapter 64E-16, Florida Administrative Code, instructs biomedical waste facilities in providing training to personnel whose responsibilities include some aspect of managing biomedical waste. Such personnel receive training prior to assuming any duties associated with biomedical waste and also thereafter receive an annual refresher course. Training details the procedures included in the facility's written operating plan, as well as compliance with Chapter 64E-16, Florida Administrative Code. A video on VHS tape, CD, or DVD to assist in training can be purchased from the Department of Health for $22.00. The order form can be downloaded from below.
If you are in business as a biomedical waste generator or transporter, or operate a storage or treatment facility, or intend to do so, you can download from below the permit, registration, and report forms you need.
Applications and Forms
The rules and forms for this program are available from the links listed below. All the links below open a new window.
(NOTE: Before applying for any biomedical waste permit, a transporter registration, or for a generator exemption, please contact your local County Health Department for current information concerning the correct mailing address and fee.)
- Application for Biomedical Waste Generator Permit/Exemption: DH4089 (21kb PDF)
- Application for Biomedical Waste Transporter Registration: DH4106 (19kb PDF)
- Application for Biomedical Waste Treatment Permit: DH4111 (19kb PDF)
- Application for Biomedical Waste Storage Permit: DH4107 (19kb PDF)
- Application for Biomedical Waste Sharps Collection Program Permit: DH4108 (8kb PDF)
- Biomedical Waste Transporter Annual Report: DH 4109 (10kb PDF)
- Biomedical Waste Treatment Facility Annual Report: DH4110 (10kb PDF)
- Biomedical Waste Operating Plan: Plan (38kb PDF)
- Biomedical Waste Training Video: Order Form (8kb PDF)
- Biomedical Waste Rules: Chapter 64E-16, FAC (60kb PDF)
- Biomedical Waste Receipt Log: (14kb PDF)
- Biomedical Waste Transport Log: (16kb PDF)
- Biomedical Waste Non Regular Pickup Log: (18kb PDF)
How to Apply for a Permit
(NOTE: Before applying for a permit, please contact your local County Health Department for current information concerning the correct mailing address and any local fee.)
Biomedical Waste Generator Permits (issued to facilities that produce biomedical waste) are issued by area Biomedical Waste Coordinators. To find out who your coordinator is, check the list of Biomedical Waste Coordinators. To apply for the permit, complete and return the Application for Biomedical Waste Generator Permit/Exemption (21kb PDF), form DH4089, to your Biomedical Waste Coordinator along with the $85.00 annual fee.
Individuals interested in transporting biomedical waste need a Biomedical Waste Transporter Registration. To register as a transporter, complete Department of Health form DH 4106 (19kb PDF) and submit it to your area biomedical waste coordinator. The fee for transporter registration varies, as it is based on the number of transport vehicles used. Your area biomedical waste coordinator will help you determine the correct fee for your business. Rules relative to biomedical waste transport are included in Chapter 64E-16, Florida Administrative Code (60kb PDF).
Biomedical waste storage facilities also need a permit. A completed Application for Biomedical Waste Storage Permit, form DH4107 (19kb PDF), should be submitted with the $85.00 fee to your area biomedical waste coordinator. Rules for storage facilities are included in Chapter 64E-16, Florida Administrative Code (60kb PDF).
To obtain a permit for the commercial treatment of biomedical waste, complete an Application for Biomedical Waste Treatment Permit, form DH4111 (19kb PDF), and submit it to your area biomedical waste coordinator along with the $85.00 fee. Rules for treatment facilities are included in Chapter 64E-16, Florida Administrative Code (60kb PDF).
To apply for a sharps collection program permit, complete and return an Application for Biomedical Waste Sharps Collection Program Permit, form DH4108 (8kb PDF), to your area biomedical waste coordinator. There is no charge for this permit. Rules for sharps collection programs are included in Chapter 64E-16, FAC (60kb PDF).