64E-16.011. Permits

(1) All biomedical waste facilities, except those facilities operating under a Department of Environmental Protection permit, shall obtain a permit from the department annually. Application forms and annual report forms used by the public may be obtained from the environmental health section of the county health department in the county of their location or from the Department of Health, Bureau of Facility Programs, 4052 Bald Cypress Way, Bin A08, Tallahassee, Florida 32399-1710. All forms listed in this section are incorporated by reference.

(a) A biomedical waste generator, who produces or treats less than 25 pounds of biomedical waste in each 30 day period, shall be exempt from all permit and fee requirements of this chapter.

(b) Application for an initial biomedical waste generator permit or exemption from permitting shall be submitted to the department on form DH 4089, Application for Biomedical Waste Generator Permit/Exemption, 8/98. Biomedical waste treatment facilities which were constructed prior to December 31, 1995, or for which an operation permit was submitted to the Department of Environmental Protection prior to December 31, 1995, shall meet the requirements of this chapter at the time of renewal of their existing permit.

(c) Application for an initial biomedical waste storage facility permit shall be submitted to the department on form DH 4107, Application for Biomedical Waste Storage Permit, 8/98.

(d) Application for an initial biomedical waste treatment facility permit shall be submitted to the department on form DH 4111, Application for a Biomedical Waste Treatment Permit, 8/01. Renewals will not be considered complete without the submission of an annual report submitted on form DH 4110, Biomedical Waste Treatment Facility Annual Report, 8/01.

(e) Application for an initial biomedical waste sharps collection program permit shall be submitted to the department on form DH 4108, Application for Biomedical Waste Sharps Collection Program Permit, 8/98.

(f) Permits shall not be transferable from one person to another. In the event of an address or name change, an amended application for permit shall be submitted to the department. A permitted generator may work at a branch office for no more than six hours in any seven day period without applying for an additional permit. These generators must notify the local county health department biomedical waste coordinator of the existence and operating hours of the branch office.

1. In the event of a change of ownership of the facility or a newly constructed facility, an application for an initial permit shall be submitted to the department within 30 days of the commencement of business.

2. When a facility is leased by the owner to a second party for operation, the second party shall apply to the department for an initial permit within 30 days of the commencement of business. The second party shall be held responsible for the operation and maintenance of the facility.

(g) Permits shall expire on September 30 each year. The permit, or a copy thereof, shall be maintained within the facility and shall be made available for review by department personnel.

(2) Persons engaged in a sharps collection program with single or multiple facility locations may operate under a single permit provided:

(a) The sharps collection program is open to the general public;

(b) A list identifying the location of each facility is attached to the application; and

(c) Each facility meets the applicable permit requirements.

Specific Authority 381.006, 381.0098 FS. Law Implemented 381.006, 381.0098 FS. History–New 12-14-92, Amended 1-23-94, 6-3-97, Formerly 10D-104.0076, Amended 11-5-02.