The Florida Senate

381.0098  Biomedical waste.--

(1)  LEGISLATIVE INTENT.--It is the intent of the Legislature to protect the public health by establishing standards for the safe packaging, transport, storage, treatment, and disposal of biomedical waste. Except as otherwise provided herein, the Department of Health shall regulate the packaging, transport, storage, and treatment of biomedical waste. The Department of Environmental Protection shall regulate onsite and offsite incineration and disposal of biomedical waste. Consistent with the foregoing, the Department of Health shall have the exclusive authority to establish treatment efficacy standards for biomedical waste and the Department of Environmental Protection shall have the exclusive authority to establish statewide standards relating to environmental impacts, if any, of treatment and disposal including, but not limited to, water discharges and air emissions. An interagency agreement between the Department of Environmental Protection and the Department of Health shall be developed to ensure maximum efficiency in coordinating, administering, and regulating biomedical wastes.

(2)  DEFINITIONS.--As used in this section, the term:

(a)  "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 470.

(b)  "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.

(c)  "Department" means the Department of Health.

(d)  "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.

(e)  "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.

(3)  OPERATING STANDARDS.--The department shall adopt rules necessary to protect the health, safety, and welfare of the public and to carry out the purpose of this section. Such rules shall address, but need not be limited to, the packaging of biomedical waste, including specific requirements for the segregation of the waste at the point of generation; the safe packaging of sharps; the placement of the waste in containers that will protect waste handlers and the public from exposure; the appropriate labeling of containers of waste; written operating plans for managing biomedical waste; and the transport, storage, and treatment of biomedical wastes.

(4)  PERMITS AND FEES.--

(a)  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.

(b)  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.

(c)  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.

(d)  The permit for a biomedical waste generator shall not be transferred from one owner to another. When the ownership or name of a biomedical waste generator 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.

(e)  A permit which the department may require by rule, for the storage or treatment of biomedical waste, may not be transferred by the permittee to any other entity, except in conformity with the requirements of this paragraph.

1.  Within 30 days after the sale or legal transfer of a permitted facility, the permittee shall file with the department an application for transfer of a permit on such form as the department shall establish by rule. The form must be completed with the notarized signatures of both the transferring permittee and the proposed permittee.

2.  The department shall approve the transfer of a permit unless it determines that the proposed permittee has not provided reasonable assurances that the proposed permittee has the administrative, technical, and financial capability to properly satisfy the requirements and conditions of the permit, as determined by department rule. The determination shall be limited solely to the ability of the proposed permittee to comply with the conditions of the existing permit, and it shall not concern the adequacy of the permit conditions. If the department proposes to deny the transfer, it shall provide both the transferring permittee and the proposed permittee a written objection to such transfer together with notice of a right to request a proceeding on such determination under chapter 120.

3.  Within 90 days after receiving a properly completed application for transfer of a permit, the department shall issue a final determination. The department may toll the time for making a determination on the transfer by notifying both the transferring permittee and the proposed permittee that additional information is required to adequately review the transfer request. Such notification shall be provided within 30 days after receipt of an application for transfer of the permit, completed pursuant to this paragraph. If the department fails to take action to approve or deny the transfer within 90 days after receipt of the completed application or within 90 days after receipt of the last item of timely requested additional information, the transfer shall be deemed approved.

4.  The transferring permittee is encouraged to apply for a permit transfer well in advance of the sale or legal transfer of a permitted facility. However, the transfer of the permit shall not be effective prior to the sale or legal transfer of the facility.

5.  Until the transfer of the permit is approved by the department, the transferring permittee and any other person constructing, operating, or maintaining the permitted facility shall be liable for compliance with the terms of the permit. Nothing in this section shall relieve the transferring permittee of liability for corrective actions that may be required as a result of any violations occurring prior to the legal transfer of the permit.

(f)  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 promulgated by rule of the department. Facilities owned and operated by the state shall be exempt from the payment of any fees.

(g)  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.

(h)  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.

(i)  The department is authorized to 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 which develops or sponsors a sharps collection program.

(5)  TRANSPORTERS.--Any person who transports biomedical waste within the state must register with the department prior to engaging in the transport of biomedical waste in accordance with rules promulgated by the department. The department may charge registration fees in the same manner as is provided in paragraphs (4)(f) and (g). The department may exempt from this requirement any person who, or facility that, transports less than 25 pounds of such waste on any single occasion.

(6)  TRACKING SYSTEM.--The department shall adopt rules for a system of tracking biomedical waste.

(a)  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.

(b)  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.

(c)  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.

(7)  ENFORCEMENT AND PENALTIES.--Any person or public body in violation of this section or rules adopted under this section is subject to penalties provided in ss. 381.0012, 381.0025, and 381.0061. However, an administrative fine not to exceed $2,500 may be imposed for each day such person or public body is in violation of this section. The department may deny, suspend, or revoke any biomedical waste permit or registration if the permittee violates this section, any rule adopted under this section, or any lawful order of the department.

(8)  PREEMPTION OF AUTHORITY TO REGULATE.--The regulation and inspection of biomedical waste generators is hereby preempted by the state. Nothing in this chapter shall be construed to affect a local government's zoning and land use authority over biomedical waste generators. Acute care hospitals, licensed under chapter 395, which utilize a certified onsite treatment process involving grinding and treatment, may dispose of such treated biomedical waste in the normal municipal solid waste stream upon notifying the local governments that are responsible for solid waste collection and disposal.

(9)  TRANSITION.--

(a)  Nothing in this act is intended to repeal or modify any existing rules of the Department of Environmental Protection relating to biomedical waste unless such rule or part thereof is in direct conflict with this act. Rules of the Department of Environmental Protection relating to transport, storage, or treatment of biomedical waste existing on the effective date of this act shall remain in effect and be enforceable by the department until comparable rules are adopted by the department, and no judicial or administrative proceeding pending on the effective date of this act shall be abated as a result of the provisions of this act.

(b)  Any person operating or in the process of constructing a biomedical storage or treatment facility, or any person transporting biomedical waste, in accordance with a permit or registration issued by the Department of Environmental Protection on the effective date of this act, may continue to operate under that permit or registration until that permit or registration expires, or until December 31, 1996, whichever is later. The department's rules concerning the permitting or registering of biomedical waste storage facilities, treatment facilities, and transporters shall be designed to accomplish a smooth transition between permitting or registration authorities.

(c)  A permit application which is received after or which is pending on the effective date of this act, which would have been considered a renewal application if submitted to the Department of Environmental Protection, will be considered a renewal application for purposes of s. 120.60 when submitted to the department.

(d)  Prior to implementing the change in the regulation of offsite treatment facilities described in this act, and after full consultation with affected persons, the department and the Department of Environmental Protection shall establish an interagency agreement to streamline the permitting and inspection of these treatment facilities. The agreement also shall be designed to avoid any duplicative or overlapping regulation of these treatment facilities. Such agreement shall at least provide:

1.  That the Department of Environmental Protection will continue to accept and act on permit applications for these facilities;

2.  That the department will review these permit applications with respect to those matters within its jurisdiction;

3.  That these permits will be consolidated with other required Department of Environmental Protection permits, where possible; and

4.  That any inspections will be consolidated to avoid duplicate inspections, where possible.

History.--s. 51, ch. 88-130; s. 2, ch. 89-138; s. 42, ch. 91-297; s. 1, ch. 92-104; s. 6, ch. 93-207; s. 353, ch. 94-356; s. 1, ch. 96-284; s. 184, ch. 97-101; s. 13, ch. 98-151.

Note.--Former s. 381.80.