64E-16.007. Treatment

(1) Biomedical waste shall be treated by steam, incineration, or an alternative process approved by the department as described in Section 64E-16.007(4), F.A.C., prior to disposal. Treatment shall occur within 30 days of collection from the generator.

(2) Steam treatment units shall subject loads of biomedical waste to sufficient temperature, pressure, and time to demonstrate a minimum Log 4 kill of Bacillus stearothermophilus spores placed at the center of the waste load, and shall be operated in accordance with the following:

(a) Before placing a steam treatment unit into service, operating parameters such as temperature, pressure, and treatment time shall be determined according to the following:

1. Test loads of biomedical waste which consist of the maximum weight and density of biomedical waste to be treated shall be prepared. Separate loads of red bags, sharps containers, boxes, and compacted waste shall be prepared if they are to be treated separately.

2. Prior to treatment, Bacillus stearothermophilus spores shall be placed at the bottom and top of each treatment container, at the front of each treatment container at a depth of approximately one-half of the distance between the top and bottom of the load, in the approximate center of each treatment container, and in the rear of each treatment container at a depth of approximately one-half of the distance between the top and bottom of the load.

3. If the operating parameters used during the treatment of the test loads demonstrate a minimum Log 4 kill of Bacillus stearothermophilus spores at all locations, the steam treatment unit shall operate under those parameters when placed into service. If the operating parameters fail to provide a minimum Log 4 kill of Bacillus stearothermophilus spores at all locations, treatment time, temperature, or pressure shall be increased and the tests must be repeated until a minimum Log 4 kill of Bacillus stearothermophilus spores is demonstrated at all locations. The steam treatment unit shall be operated under those parameters when placed into service. Tests shall be repeated and new parameters established if the type of biomedical waste to be treated is changed.

(b) When operating parameters have been established and documented using the criteria in paragraph 64E-16.007(2)(a), F.A.C., the steam treatment unit may be placed into service.

(c) The steam treatment unit shall be serviced for preventive maintenance in accordance with the manufacturer's specifications. Records of maintenance shall be onsite and available for review.

(d) Unless a steam treatment unit is equipped to continuously monitor and record temperature and pressure during the entire length of each treatment cycle, each package of biomedical waste to be treated will have a temperature tape or equivalent test material such as a chemical indicator placed on a non-heat conducting probe at the center of each treatment container in the load that will indicate if the treatment temperature and pressure have been reached. Waste shall not be considered treated if the tape or equivalent indicator fails to show that a temperature of at least 250 degrees F (121 degrees C) was reached during the process.

(e) Each steam treatment unit shall be evaluated for effectiveness with spores of Bacillus stearothermophilus at least once each 7 days for permitted treatment facilities, or once each 40 hours of operation for generators who treat their own biomedical waste. The spores shall be placed at the center of the waste load. Evaluation results shall be maintained onsite and available for review.

(f) A written log shall be maintained for each steam treatment unit. The following shall be recorded for each usage:

1. The date, time, and operator name;

2. The type and approximate amount of waste treated;

3. The post-treatment confirmation results by either

a. recording the temperature, pressure, and length of time the waste was treated, or

b. the temperature and pressure monitoring indicator;

(g) A current written operating procedure shall specify, at a minimum, the following:

1. Parameters, determined from testing, that provide consistent treatment, such as exposure time, temperature, and pressure.

2. Identification of standard treatment containers and placement of the load in the steam treatment unit.

(3) Incineration of biomedical waste shall be achieved in a biological waste incinerator permitted by the Department of Environmental Protection.

(4) An alternative treatment process, such as chemical, gas, dry heat, or microwave shredding, shall be considered by the department upon receipt of a written request. The written request shall be directed to the State Health Officer and shall include:

(a) The specific treatment process and type of facility for which acceptance is sought;

(b) The reason for the request;

(c) Microbiological evidence, using the organisms listed in Table 1, that the proposed process provides sterilization or a satisfactory level of disinfection. Using the protocol described in Section 64E-16.007(4), F.A.C., alternative treatment systems must show either:

1. For disinfection, a minimum Log 6 kill for 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, or

2. For sterilization, 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.

Table 1

1. Bacteria

a. Bacillus spores – mandatory, species determined by treatment process

Any two

b. Enterococcus faecalis

c. Pseudomonas aeruginosa

d. Staphylococcus aureus

e. Nocardia species

2. Mycobacteria species – any one

a. Mycobacterium bovis

b. Mycobacterium fortuitum

3. Fungus – any one

a. Candida albicans

b. Aspergillus fumigatus

4. Protozoa – Giardia intestinalis or similar

5. Virus – Poliovirus or similar.

(d) Each step of the efficacy testing must be thoroughly described in the application for approval. A detailed description of the treatment process, preparation of organisms, preparation of test loads, recovery of organisms, and raw data must be provided.

(e) To begin the efficacy testing, two challenge loads must be sterilized. These loads must be composed of materials commonly found in biomedical waste (tissues, sharps, plastics, glass, woven materials, blood and blood products, etc.), and must be of adequate quantity to equal the maximum capacity of the treatment system. The test load must be fully described (weight, moisture content, composition, etc.).

(f) The purity of all organisms and spores must be certified by a clinical or commercial laboratory. Each organism must be processed separately and placed in the test load in the most difficult location to treat. Before each test run, the total number of viable test organisms must be determined and documented. Treatment of the test load must take place within thirty minutes of inoculating the load with the test organism.

(g) The test load containing the test organism must be processed without the agent (e.g., chemical, microwaves, etc.) used to kill the test organisms. If this agent is a liquid, it must be replaced with an equal amount of sterile saline solution or tapwater. After the test load has completed one cycle in the treatment device, a minimum of three grab samples must be taken from the test load and the number of test organisms present determined. If the number of organisms recovered after the test run is less than Log 6, the number of organisms originally introduced into the device must be increased, and the run must be performed again, until at least Log 6 organisms are recovered. If the number of organisms recovered from the test run is Log 6 or greater, there is an adequate number of organisms being introduced into the device, and the inoculum size should be equal to this number.

(h) Using the inoculum size determined in the above procedure, the second sterilized test load must be inoculated separately. During these test runs, the chemical or physical agent used to treat the waste must be used.

(i) After each test run is completed, the log kill for that particular organism or spore must be calculated. The number of organisms that were not recovered from the initial (non-treating) test run must be subtracted from the number of organisms that were introduced into the second (treatment) run. The number of organisms that survive the treatment process must be subtracted from the first calculation. The resulting figure is the log kill provided by the treatment process.

(j) Approved alternative treatment processes, except single-use, shall meet the requirements of subsection 64E-16.007(2)(e).

(5) Biomedical waste may be disposed into a sanitary sewer system, an onsite sewage treatment and disposal system, or other system approved to receive such waste by The Department of Environmental Protection or the department, if it is in a liquid or semi-solid form and aerosol formation is minimal.

(6) Body tissues that have been histologically fixed are considered treated biomedical waste. Tissues prepared by frozen sectioning only are not considered treated.

(7) Acute care hospitals, licensed under Chapter 395, F.S., 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 government responsible for solid waste collection and disposal under the following conditions:

(a) For the purposes of this chapter, certified shall mean that the treatment process is steam treatment, or has been approved as an alternative biomedical waste treatment process under Section 64E-16.007(4), F.A.C.

(b) For the purposes of this chapter, grinding shall also mean shredding or hammermilling.

(c) If grinding takes place prior to treatment, procedures that minimize the chance of exposure to waste handlers must be developed and implemented should the grinder fail or become jammed.

(d) Individuals operating the treatment unit must be trained in all aspects of its operation, including contingency procedures.

(e) Acute care hospitals must inform the department in writing of the installation of the unit at least 30 days prior to placing the unit into service.

(f) Inspection of the unit, including treatment and maintenance records, will occur during the annual inspection for the hospital's biomedical waste permit.

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 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly 10D-104.007.