(a) A large quantity generator (LQG) that treats all or part of the medical waste generated on-site shall provide written notification to the executive director of the operation of an approved treatment process unit used only for the treatment of medical waste generated on-site in accordance with the provisions of 25 TAC §1.136 (relating to Approved Methods of Treatment and Disposition). Alternative treatment technologies may be approved in accordance with requirements found in 25 TAC §1.135 (relating to Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities). This one-time notification shall include:
  (1) the contact information for the generator;
  (2) if applicable, the name, address, telephone number, and the Texas Commission on Environmental Quality authorization number of the mobile treatment operator providing treatment; and
  (3) the method/conditions of treatment.
(b) A LQG shall maintain on-site a written record that contains the information listed in subsection (a) of this section and the following:
  (1) the name (printed) and initials of the person(s) performing treatment;
  (2) the dates of treatment;
  (3) the amounts of waste treated; and
  (4) written procedure for the operation and testing of any equipment used and written procedure for the preparation of any chemicals used in the treatment.
    (A) The operator shall demonstrate a minimum four log ten reduction (as defined in 25 TAC §1.132 (relating to Definitions)) on routine performance testing using appropriate Bacillus species biological indicators (as defined in 25 TAC §1.132). The operator shall conduct testing at the following intervals:
      (i) for generators of more than 50 pounds but less than or equal to 100 pounds per month, testing shall be conducted at least once per month;
      (ii) for generators of more than 100 pounds but less than or equal to 200 pounds per month, testing shall be conducted at least every two weeks; and
      (iii) for generators of more than 200 pounds per month testing shall be conducted at least weekly.
    (B) For those processes that the manufacturer has documented compliance with the performance standard prescribed in 25 TAC §1.135, based on specified parameters (for example, pH, temperature, pressure), and for previously approved treatment processes that a continuous readout and record of operating parameters is available, the operator may substitute routine parameter monitoring for biological monitoring. The operator shall confirm that any chemicals or reagents used as part of the treatment process are at the effective treatment strength. The operator will maintain records of operating parameters and reagent strength, if applicable, for three years.
    (C) The manufacturer of single-use, disposable treatment units shall be responsible for maintaining adequate quality control for each lot of single-use products. The treating facility or entity shall be responsible for following the manufacturer's instructions.
    (D) Owners or operators of medical waste incinerators shall comply with the requirements in §111.123 of this title (relating to Medical Waste Incinerators) in lieu of biological or parametric monitoring.
(c) Disposal of treated medical waste. Medical wastes that have been treated in accordance with the provisions of 25 TAC §1.136 may be managed as routine municipal solid waste unless otherwise specified in paragraphs (1) - (5) of this subsection.
  (1) Incinerator ash shall be disposed of in a permitted landfill in accordance with Chapter 330 of this title (relating to Municipal Solid Waste).
  (2) Treated microbiological waste, blood, blood products, body fluids, laboratory specimens of blood and tissue, and animal bedding may be disposed of in a permitted landfill. Any markings that identify the waste as a medical waste shall be covered with a label that identifies the waste as treated medical waste. The identification of the waste as treated may be accomplished by the use of color-coded, disposable containers for the treated waste or by a label that states the contents of the disposable container have been treated in accordance with the provisions of 25 TAC §1.136.
  (3) Treated carcasses and body parts of animals designated as a medical waste may, after treatment, be disposed of in a permitted landfill in accordance with Chapter 330 of this title. The collection and transportation of these wastes shall conform to the applicable local ordinance or rule, if such ordinance or rule is more stringent than this subsection.
  (4) Treated recognizable human body parts, tissues, fetuses, organs, and the products of human abortions, spontaneous or induced, shall not be disposed of in a municipal solid waste landfill. These items shall be disposed of in accordance with the provisions of 25 TAC §1.136(a)(4).
  (5) Sharps treated and containerized with one of the approved methods as described under 25 TAC §1.136(a)(5) shall be disposed of in a permitted landfill in accordance with Chapter 330 of this title. Unused sharps shall be disposed of as treated sharps.

Source Note: The provisions of this §326.41 adopted to be effective May 26, 2016, 41 TexReg 3697