64E-16.002. Definitions

For the purpose of this chapter, the following words and phrases shall have the meanings indicated:

(1) American Society for Testing Materials, also referred to as ASTM – A technical society with headquarters located at 100 Barr Harbor Drive, West Conshohocken, Pennsylvania, 19428-2959, which publishes national standards for the testing and quality assurance of materials.

(2) Biomedical waste – Any solid or liquid waste which may present a threat of infection to humans, including nonliquid tissue, body parts, blood, blood products, and body fluids from humans and other primates; laboratory and veterinary wastes which contain human disease-causing agents; and discarded sharps. The following are also included:

(a) Used, absorbent materials saturated with blood, blood products, body fluids, or excretions or secretions contaminated with visible blood; and absorbent materials saturated with blood or blood products that have dried.

(b) Non-absorbent, disposable devices that have been contaminated with blood, body fluids or, secretions or excretions visibly contaminated with blood, but have not been treated by an approved method.

(3) Biomedical waste generator – A facility or person that produces biomedical waste. The term includes 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.

(a) Mobile health care units, such as bloodmobiles, that are part of a stationary biomedical waste generator, are not considered individual biomedical waste generators.

(b) Funeral homes that do not practice embalming are not considered biomedical waste generators.

(4) Body fluids – Those fluids which have the potential to harbor pathogens, such as human immunodeficiency virus and hepatitis B virus and include blood, blood products, lymph, semen, vaginal secretions, cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids. In instances where identification of the fluid cannot be made, it shall be considered to be a regulated body fluid. Body excretions such as feces and secretions such as nasal discharges, saliva, sputum, sweat, tears, urine, and vomitus shall not be considered biomedical waste unless visibly contaminated with blood.

(5) Contaminated – Soiled by any biomedical waste.

(6) Decontamination – The process of removing pathogenic microorganisms from objects or surfaces, thereby rendering them safe for handling.

(7) Department – The Department of Health or its representative county health department.

(8) Disinfection – A process which results in a minimum Log 6 kill against the vegetative organisms listed in Table 1, and a minimum Log 4 kill against Bacillus stearothermophilus spores utilizing steam or a minimum Log 4 kill against Bacillus Subtilis spores utilizing dry heat, chemicals, or microwave shredding.

(9) Facility – All contiguous land, structures, and other appurtenances which are owned, operated, and licensed as a single entity which may consist of several generating, treatment, or storage units.

(10) Hazardous waste – Those materials defined in Chapter 62-730, F.A.C.

(11) Health Care Provider – Any person who provides medical care or personal services, as that term is defined in Section 400.402, F.S., to another individual.

(12) Home User – An individual who generates biomedical waste as a result of self-care or care by a family member or other non health care provider.

(13) Leak resistant – Prevents liquid from escaping to the environment in the upright position.

(14) Outer container – Any rigid type container used to enclose packages of biomedical waste.

(15) Packages – Any material that completely envelops biomedical waste. This includes red bags, sharps containers and outer containers.

(16) Person – Any individual, partnership, corporation, association, or public body engaged in the generation, storage, transport, or treatment of biomedical waste.

(17) Point of origin – The room or area where the biomedical waste is generated.

(18) Public sharps collection program – A cooperative program designed as a non-profit community service to assist the home user in the safe disposal of discarded sharps.

(19) Puncture resistant – Able to withstand punctures from contained sharps during normal usage and handling.

(20) Restricted – The use of any measure, such as a lock, sign, or location, to prevent unauthorized entry.

(21) Saturated – Soaked to capacity.

(22) Sealed – Free from openings that allow the passage of liquids.

(23) Sharps – Objects capable of puncturing, lacerating, or otherwise penetrating the skin.

(24) Sharps container – A rigid, leak and puncture resistant container, designed primarily for the containment of sharps, clearly labeled with the phrase and international biological hazard symbol as described in Section 64E-16.004(2)(a), F.A.C., and manufactured with dyes meeting the requirements for incidental metals as described in Section 64E-16.004(2)(b)1.b., F.A.C.

(25) Sterilization – A process which results in a minimum Log 6 kill against Bacillus stearothermophilus spores utilizing steam or a minimum Log 6 kill against Bacillus Subtilis spores utilizing dry heat, chemicals, or microwave shredding.

(26) Storage – The holding of packaged biomedical waste for a period longer than three days at a facility or in a transport vehicle.

(27) Transfer – The movement of biomedical waste within a facility.

(28) Transport – The movement of biomedical waste away from a facility.

(29) Transport vehicle – A motor vehicle, as defined in Section 320.01, F.S., a rail car, watercraft or aircraft, used for the transportation of biomedical waste.

(30) Treatment – Any process, including steam, chemicals, microwave shredding, or incineration, which changes the character or composition of biomedical waste to render it noninfectious by disinfection or sterilization.

Specific Authority 381.006, 381.0098 FS. Law Implemented 381.006, 381.0098, 395.002(13), 395.1011 FS. History–New 6-19-89, Amended 4-2-90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly 10D-104.002.