BUREAU PROGRAMS

• Biomedical Waste
• Black Henna
• Body Piercing
• Certification of Environmental Health Professional
• Compressed Air Program
• Food Hygiene
• Group Care Facilities
• Indoor Air Quality
• Internship in Environmental Health
• Migrant Labor Camps
• Mobile Home and Recreational Vehicle Parks
• Radon Program
• Tanning Facilities

Biomedical Waste Program

Contact Info: Gina Vallone-Hood or Penny Barwick DOH-HSEC 4052 Bald Cypress Way, BIN A08, Tallahassee, Florida, 32399-1710. (850) 245-4277 FAX (850) 487-0864

More Info: Biomedical Waste Statewide Coordinators Registered Biomedical Waste Transporters Local Sharps Collection Programs Home Management of Sharps (Needles, etc.)

There are approximately 38,000 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-service staff, waste haulers, and the general public from risks associated with potentially infectious biomedical waste.

Both the Department of Health and the Florida Department of Environmental Protection 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.  Chapter 64E-16, Florida Administrative Code (F.A.C.)(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.

Business Issues

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 25,000 such facilities are inspected annually.  However, the approximately 14,000 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

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, F.A.C. (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, F.A.C.  Other red bags also may be used if they meet the construction standards required by Chapter 64E-16, F.A.C.

Chapter 64E-16, F.A.C., 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, F.A.C.  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.

Rule Promulgation

Rule Promulgation is the process by which the Department of Health develops and adopts rules authorized by the Legislature. The Bureau of Community Environmental Public Health develops and adopts Rule Chapter 64E-16, F.A.C., for tracking the management of biomedical waste. The proposed rule amendments (pdf 1mb, opens in new window) update existing biomedical waste rules that have not been revised since 1997. Due to the nature of the revisions, a strike-all of existing language was recommended by legal counsel, which allowed for an extensive re-organization of the rules.

The Process

When the Department contemplates making a change to the rules, it must publish a Notice of Rule Development. All notices are published in the Florida Administrative Weekly (F.A.W.). (opens in new window) The Department will hold public meetings or workshops to develop and refine the actual rule language in conjunction with industry representatives. Once these efforts have been completed, the Department publishes a Notice of Rulemaking in the F.A.W. The industry again has the opportunity to respond with written comments or oral testimony at a public hearing following publication of the Notice of Rulemaking. The Department has the opportunity to make changes to the rule based upon comments received in these venues. Any changes must be published in a Notice of Change. Following publication of the changes, the Department may file the rule for adoption.

Rule Development
• A workshop was held from 9:00 AM to 12:00 PM on Monday, November 15, 2010, at the Florida Department of Health, Bureau of Community Environmental Public Health, 4042 Bald Cypress Way, Room 301, Tallahassee, Florida, 32399. Text in red font in the proposed rule amendments (pdf 1mb, opens in new window) was added based on the comments received at the workshop.

Rulemaking
• Not yet announced in the FAW.

Filing for Adoption
• None

Questions or comments can be directed to (Under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead contact these offices by phone or in writing.) Gina Vallone-Hood or Penny Barwick at the Bureau of Community Environmental Public Health, HSEC, 4052 Bald Cypress Way, BIN A08, Tallahassee, Florida, 32399-1710. Ms. Vallone-Hood or Ms. Barwick can be reached by telephone at (850) 245-4277.
 

Download Files 

The rules and forms for this program are available from the links listed below.  All the files are in pdf format.  If your computer cannot read pdf files, you can download Adobe Acrobat Reader, at no charge, from the Adobe Internet site at http://www.adobe.com/ .  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 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)
• Application for Biomedical Waste Treatment Permit DH4111 (19kb PDF)
• Biomedical Waste Training Video: Order Form (8kb PDF)
• Biomedical Waste Rules Chapter 64E-16, F.A.C. (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

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 Department of Health form DH4089 (21kb PDF) 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, F.A.C. (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, F.A.C. (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, F.A.C. (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, F.A.C. (60kb PDF) .

Contacts

Under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing. General questions concerning the biomedical waste program that you may wish to send via e-mail can be directed to Gina Vallone-Hood or Penny Barwick, in the Bureau of Community Environmental Public Health, HSEC, 4052 Bald Cypress Way,
Bin A08, Tallahassee, Florida, 32399-1710.  Ms. Vallone-Hood and Ms. Barwick can be reached by telephone at (850) 245-4277.

Comments and Suggestions

We welcome your comments and suggestions. Under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing. Any e-mail you may wish to submit to us will be used to improve the services provided by this website and can be directed to Gina Vallone-Hood or Penny Barwick.