R315-316-5. Infectious Waste Treatment and Disposal Requirements

  (1) Infectious waste shall be treated or disposed as soon as possible and shall be treated or disposed at a facility with a permit or other form of approval allowing the facility to treat or dispose infectious waste.

  (2)(a) All material that has been rendered non-infectious through an approved treatment method may be handled as non-infectious solid waste, provided it is not otherwise a hazardous waste or a radioactive waste excluded from disposal in a solid waste facility by Rules R315-301 through 320.

  (b) Except for incineration and steam sterilization, no treatment method may be used to render materials non-infectious without receiving prior approval from the Director.

  (3) Infectious waste may be incinerated in an incinerator provided the incinerator is permitted or approved under Rules R315-301 through 320.

  (4) Infectious waste may be sterilized by heating in a steam sterilizer to render the waste non-infectious.

  (a) The operator shall have available, and shall certify in writing that he understands, written operating procedures for each steam sterilizer, including time, temperature, pressure, type of waste, type of container, closure of container, pattern of loading, water content, and maximum load quantity.

  (b) Infectious waste shall be subjected to sufficient temperature, pressure and time to inactivate Bacillus stearothermophilus spores in the center of the waste load at a 6 Log₁₀ reduction or greater.

  (c) Unless a steam sterilizer is equipped to continuously monitor and record temperature and pressure during the entire length of each sterilization cycle, each package of infectious waste to be sterilized shall have a temperature-sensitive tape or equivalent test material, such as chemical indicators, attached that will indicate if the sterilization temperature and pressure have been reached. Waste shall not be considered sterilized if the tape or equivalent indicator fails to indicate that a temperature of at least 250 degrees Fahrenheit (121 degrees Celsius) was reached and a pressure of at least 15 psi was maintained during the process.

  (d) Each sterilization unit shall be evaluated for effectiveness with spores of B. stearothermophilus at least once each 40 hours of operation or each week, whichever is less frequent.

  (e) A written log for each load shall be maintained for each sterilization unit which shall contain at a minimum:

  (i) the time of day and the date of each load and the operator's name;

  (ii) the amount and type of infectious waste placed in the sterilizer; and

  (iii) the temperature, pressure, and duration of treatment.

  (5)(a) Alternative treatment methods may be approved on a site-specific basis when the Director finds the proposed alternative treatment method renders the material non-infectious.

  (b) The determination shall be based on the results of laboratory tests, submitted by the person proposing the use of the treatment method, meeting the following requirements:

  (i) the laboratory tests shall be conducted:

  (A) by qualified laboratory personnel;

  (B) using recognized microbial techniques;

  (C) on samples that have been inoculated with the test organisms, then subjected to the proposed treatment method and processed in an identical way to the treatment process being proposed for approval; and

  (ii) the results of the tests must document that the proposed treatment method inactivates:

  (A) vegetative bacteria - Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15442) at a 6 Log₁₀ reduction or greater (a 99.9999% reduction or greater of the organism population);

  (B) fungi - Candida albicans (ATCC 18804), Penicillium chrysogenum (ATCC 24791), or Aspergillus niger at a 6 Log₁₀ reduction or greater;

  (C) viruses - Polio 2, Polio 3, or MS-2 Bacteriophage (ATCC15597-B1) at a 6 Log₁₀ reduction or greater;

  (D) parasites - Cryptosporidium spp. oocysts or Giardia spp. cysts at a 6 Log₁₀ reduction or greater;

  (E) mycobacteria - Mycobacterium terrae or Mycobacterium phlei at a 6 Log₁₀ reduction or greater; and

  (B) Bacterial spores - Bacillus stearothermophilus spores (ATCC 7953) or Bacillus subtilis spores (ATCC 19659) at a 4 Log₁₀ reduction or greater (a 99.99% reduction or greater of the organism population).

  (iii) The Director shall review the submitted materials and reply in writing within 30 days of the receipt of the treatment studies.

  (6) Infectious waste may be discharged to a sewage treatment system that provides secondary treatment of waste but only if the waste is liquid or semi-solid and if approved by the operator of the sewage treatment system.

  (7) Infectious waste may be disposed in a permitted Class I, II, or V Landfill. Upon entering the landfill, the transporter of infectious waste shall notify the landfill operator that the load contains infectious waste. The landfill operator shall abide by the following procedures in the disposition and covering of infectious waste:

  (a) place the infectious waste containers in the working face with sufficient care to avoid breaking them;

  (b) completely cover the infectious waste immediately with a minimum of 12 inches of earth or waste material containing no infectious waste; and

  (c) not compact the infectious waste until completely covered with 12 inches of earth or waste material containing no infectious waste.