(b) Incineration.

1. (1) Burning of medical waste in conformance with the standards prescribed by the Division of Environmental Quality or the United States Environmental Protection Agency.
2. (2) A permit must be obtained from the division before an incinerator can be installed or operated.
3. (3) Inspection of incinerators shall be conducted by the division in compliance with the federal Clean Air Act, 42 U.S.C. § 7401 et seq., and/or the Arkansas Water and Air Pollution Control Act, Arkansas Code § 8-4-101 et seq., or other applicable air regulations.

(c) Sterilization technology.

1. (1) Sterilization is the complete elimination of microbial viability.

2. (2) Procedures utilized must be performed properly and according to the manufacturer's operating instructions (with regard to time, temperature, pressure, waste exposure, and capacity), provided the results:

   1. (A) Change the biological character or composition of the medical waste completely and reliably inactivating Bacillus stearothermophilus spores or other appropriate organisms at a 4 Log 10 reduction (99.99%) or greater; and
   2. (B) Meet or exceed the parameters listed below.
3. (3) If a primary container is used, the primary container shall be placed in the sterilization chamber with sufficient space provided between the chamber walls and the container to allow the steam, heat, or chemical to surround the container and penetrate all of the medical waste.
4. (4) The primary container shall be sealed loosely enough to allow the steam to penetrate the entire contents of the container, unless a self-venting bag is used.
5. (5) All of the medical waste must be exposed to the temperatures and pressures listed below.

6. (6) Approved procedures are:

   1. (A)

(i) Steam under pressure (autoclaving). Steam at two hundred forty-eight degrees Fahrenheit (248°F) (one hundred twenty degrees Celsius (120°C)) at fifteen pounds per square inch (15 psi) for thirty (30) minutes.

1. (ii) Steam auger. Steam at two hundred five degrees Fahrenheit (205°F) (ninety-six degrees Celsius (96°C)) at fifteen pounds per square inch (15 psi) for sixty (60) minutes;

   1. (B) Dry heat. Heat at three hundred twenty degrees Fahrenheit (320°F) (one hundred sixty degrees Celsius (160°C)) at atmospheric pressure for two (2) hours;
   2. (C) Chemical vapor. Approved United States Environmental Protection Agency chemical mixture at two hundred sixty degrees Fahrenheit (260°F) (one hundred twenty-seven degrees Celsius (127°C)) at twenty pounds per square inch (20 psi) for thirty (30) minutes; and

   3. (D) Ethylene oxide.

      1. (i) Four-hour to five-hour cycle using eleven percent (11%) to twelve percent (12%) percent ethylene oxide.
      2. (ii)

(b) (b) Persons interested in applying this technology should contact the division before installing or operating such equipment.

1. (iii) Quality control of the sterilization process shall be performed at least once a month or after every forty (40) hours of operation, whichever comes later, using physical, chemical, and biological monitors (thermochemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples, etc.) placed in or on the outside of the waste containers and distributed throughout the load, chamber, or vessel during treatment as listed in 20 CAR § 53-308 to evaluate the effectiveness of the treatment process.

   1. (iv) Unless the sterilization unit is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, except for treatment using ethylene oxide, the operator of such sterilization equipment shall affix to the medical waste a temperature-sensitive tape which will indicate that the required temperature was reached.

      1. (d) Disinfection.
2. (1) A potentially less lethal process compared to sterilization that eliminates or inactivates many or all pathogenic microorganisms including viruses, fungi, and bacteria (but not necessarily all their endospores) on inanimate surfaces.

3. (2) Approved procedures are:

   1. (A) Thermal inactivation.

      1. (i) Procedure must be performed properly as indicated by the equipment manufacturer's operating instructions and the adequacy of disinfection verified by physical, chemical, and biological monitoring (thermochemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples, etc.) as listed in 20 CAR § 53-308.
      2. (ii) Unless the thermal inactivation equipment is equipped to continuously monitor and record temperatures during the entire length of each disinfection cycle, the operator shall affix to the medical waste a temperature-sensitive tape (i.e. autoclave tape) which will indicate that the required temperature was reached.
      3. (iii) Approved procedures are:

(b) (b) Microwave; and

1. (c) (c) Dielectric energy.

   1. (iv) Thermal inactivation must allow for sufficient heat to access and penetrate the waste.

      1. (v) The waste must be packaged according to the recommendations of the manufacturer and loaded into the chamber as to not exceed the capacity limits set by the manufacturer; and

   2. (B) Chemical.

      1. (i) The use of United States Environmental Protection Agency-approved chemical agents to significantly reduce microbial activity for waste treatment, e.g., one (1) part freshly prepared solution of free available chlorine (hypochlorite bleach) concentration to no more than ten (10) parts water (1:10 dilution) for at least ten (10) minutes.
      2. (ii) The chemical agent shall be used according to the manufacturer's instructions.
      3. (iii) The chemical agent must penetrate all the waste material.
      4. (iv) If liquid chemical disinfectants or sterilants are used, excess liquid must be drained prior to disposal.
      5. (v) Certain chemical disinfectants or sterilants may not be allowed to be discharged to a POTW.
      6. (vi) Solid waste landfills are prohibited from accepting liquids or wastes containing free liquids and/or infectious waste as outlined in the division’s Solid Waste Management Code, 8 CAR pt. 60.

(g) Other available technology (alternate technology).

1. (1) Technology other than listed above in subsections (b) – (f) of this section shall be evaluated and approved by the department.
2. (2) Alternate technologies are usually approved at the manufacturer level.

3. (3) Applications for approval of an alternate technology must be made on forms provided by the department’s Medical Waste Program criteria used to evaluate alternate technologies will include, but not be limited to:

   1. (A) Approval by states other than Arkansas that utilize a performance standards approach to review alternate treatment technologies;
   2. (B) Environmental impact;
   3. (C) Environmental permit requirements;
   4. (D) Potential worker health effects;
   5. (E) Manufacturer operating requirements and instructions; and

   6. (F) Levels of microbial inactivation which includes:

      1. (i) Inactivation of representative samples of mycobacteria, at a level of 6 log 10 (99.9999%) reduction or more, as determined by the department; and
      2. (ii) Inactivation of Geobacillus stearothermophilus endospores or Bacillus atrophaeus endospores at a level of 4 log 10 (99.99%) reduction or more, as determined by the department.
4. (4) One (1) or more representative surrogate microorganisms from each microbial group shall be used in treatment efficacy evaluations.
5. (5) The department shall determine the appropriate microorganisms to serve as representative surrogate microorganisms.
6. (6) Protocols developed for efficacy testing shall incorporate, as applicable, recognized standard procedures.
7. (7) Guidelines for testing and approval of alternate medical waste technologies may be obtained from the department’s Medical Waste Program.

8. (8) The department shall maintain a list of those approved alternate technologies, including:

   1. (A) Manufacturer;
   2. (B) Product name;
   3. (C) Model number; or
   4. (D) Other appropriate identifying information.
9. (10) The list shall be made available by the department’s Medical Waste Program.