The Florida Senate

“Biomedical waste” means any solid or liquid waste which 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 which contains human-disease-causing agents; discarded disposable sharps; human blood, blood products, and body fluids; and other materials which in the opinion of the department 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 generator” means a facility or person that produces or generates biomedical waste. The term includes, but is not limited to, hospitals, skilled nursing or convalescent hospitals, intermediate care facilities, clinics, dialysis clinics, dental offices, health maintenance organizations, surgical clinics, medical buildings, physicians’ offices, laboratories, veterinary clinics, and funeral homes where embalming procedures are performed.

“Department” means the Department of Health.

“Sharps” mean those biomedical wastes which as a result of their physical characteristics are capable of puncturing, lacerating, or otherwise breaking the skin when handled.

“Treatment” means any process, including steam treatment, chemical treatment, and microwave shredding, which changes the character or composition of biomedical waste so as to render it noninfectious. For the purposes of this section, treatment does not include the incineration of biomedical waste.

All persons who generate, store, or treat biomedical waste shall obtain a permit from the department prior to commencing operation, except that a biomedical waste generator generating less than 25 pounds of biomedical waste in each 30-day period shall be exempt from the registration and fee requirements of this subsection. A biomedical waste generator need not obtain a separate permit if such generator works less than 6 hours in a 7-day period at a location different than the location specified on the permit. The department may issue combined permits for generation, storage, and treatment as appropriate to streamline permitting procedures. Application for such permit shall be made on an application form provided by the department and within the timeframes and in the manner prescribed by department rule.

Once the department determines that the person generating, storing, or treating biomedical waste is capable of constructing a facility or operating in compliance with this section and the rules adopted under this section, the department shall grant the permit.

If the department determines that the person generating, storing, or treating biomedical waste does not meet the provisions outlined in this section or the rules adopted under this section, the department shall deny the application for the permit pursuant to provisions of chapter 120. Such denial shall be in writing and shall list the circumstances for denial. Upon correction of such circumstances, the permit shall be issued.

The permit for a biomedical waste facility may not be transferred. When the ownership, control, or name of a biomedical waste facility is changed and continues to operate, the new owner shall apply to the department, upon forms provided by the department, for issuance of a permit in the timeframe and manner prescribed by rule of the department.

The department shall establish a schedule of fees for such permits. Fees assessed under this section shall be in an amount sufficient to meet the costs of carrying out the provisions of this section and rules adopted under this section. The fee schedule shall not be less than $50 or more than $400 for each year the permit is valid. Fees may be prorated on a quarterly basis when a facility will be in operation for 6 months or less before the annual renewal date. The department shall assess the minimum fees provided in this subsection until a fee schedule is adopted by rule of the department. Facilities owned and operated by the state shall be exempt from the payment of any fees.

Fees collected by the department in accordance with provisions of this section and the rules adopted under this section shall be deposited into a trust fund administered by the department for the payment of costs incurred in the administration of this section.

Permits issued by the department shall be valid for no more than 5 years. However, upon expiration, a new permit may be issued by the department in accordance with this section and the rules of the department.

The department may develop a streamlined process for permitting biomedical waste storage facilities that accept and store only sharps collected from the public, which may include the issuance of a single permit for each applicant that develops or sponsors a sharps collection program.

Such system shall, at a minimum, provide for tracking of the transportation of the waste from the generator to the treatment or incineration facility, including a means for providing the generator of the waste assurance that the waste is received by the treatment or incineration facility, and shall include the identification of the entity transporting the waste on the container.

Inspections may be conducted for purposes of compliance with this section. Any such inspection shall be commenced and completed with reasonable promptness. If the officer, employee, or representative of the department obtains any samples, prior to leaving the premises he or she shall give the owner, operator, or agent in charge a receipt describing the sample obtained.

Any person who fails to comply with the provisions of this subsection commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.