|(a) Treatment requirements for medical waste shall be as follows. (1) Medical waste shall be treated 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). (2) A generator of 50 pounds or less per calendar month of medical waste that treats all or part of the wastes on-site shall maintain a written record that, at a minimum, contains the following information: (A) the date of treatment; (B) the amount of waste treated; (C) the method/conditions of treatment; (D) the name (printed) and initials of the person(s) performing treatment; and (E) if applicable, name, address, telephone number, and registration number of the entity providing treatment. (3) A generator of more than 50 pounds per calendar month of medical waste that treats all or part of the wastes on-site and persons that treat medical wastes off-site shall maintain a written record that, at a minimum, contains the following information for each batch of waste treated: (A) the date of treatment; (B) the amount of waste treated; (C) the method/conditions of treatment; (D) the name (printed) and initials of the person(s) performing treatment; and (E) a written procedure for the operation and testing of any equipment used and a written procedure for the preparation of any chemicals used in treatment. (i) 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 biweekly; and (III) for generators of more than 200 pounds per month and persons that treat medical wastes off-site, testing shall be conducted at least weekly. (ii) 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, etc.), 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. (iii) 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. (iv) 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. (b) Requirements for disposal of medical wastes that have been treated in accordance with the provisions of 25 TAC §1.136 are as follows. (1) 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 in accordance with the provisions of subsection (e) of this section. 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 that the contents of the disposable container have been treated in accordance with the provisions of 25 TAC §1.136. (2) 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 the provisions of §330.171(c)(2) 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 these sections. (3) 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). (4) Treated sharps shall be disposed of as follows. (A) Broken glassware and pipets may be placed in puncture-resistant packaging and discarded in a Type I or Type IAE municipal solid waste landfill. (B) Whole hypodermic needles, syringes with attached needles, scalpel blades, and/or razors shall be placed in containers designed for sharps that is marked or labeled as containing treated waste. (C) Sharps placed in containers designed for sharps may be encapsulated by addition of an agent to the container that will solidify and encase the contents of the container with a solid matrix. The agent must completely fill the container. The container and solidified contents must withstand an applied pressure of 40 pounds per square inch without disintegration. The container shall be identified as containing sharps that have been encapsulated in accordance with this subparagraph and may be discarded in a Type I or Type IAE municipal solid waste landfill. (D) Sharps that have been treated by an approved method that incorporates grinding and/or shredding may be disposed in a Type I or Type IAE municipal solid waste landfill if the sharps have been made unrecognizable and significantly reduced in ability to cause puncture wounds. (c) Unused hypodermic needles, syringes with attached needles, and scalpel blades shall be disposed of as treated sharps as specified in subsection (b)(4)(B) - (D) of this section. (d) Operators of medical waste treatment equipment shall use backflow preventers on any potable water connections to prevent contamination of potable water supplies. (e) Treated medical waste may be managed as routine municipal solid waste. Treated medical waste that contains whole, nonencapsulated hypodermic needles or syringes or intact red bags that are sent to a landfill for disposal shall be accompanied by a shipping document that includes a statement that the shipment contains whole, nonencapsulated hypodermic needles or syringes or intact red bags, as applicable, and that the medical waste was treated in accordance with 25 TAC §1.136 of this title (relating to Approved Methods of Treatment and Disposition).