All manufacturers of commercially-available alternate technologies, equipment, or processes designed or intended for the treatment of special waste from health care-related facilities, except those meeting the standards of §1.133(b) of this title (relating to Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services), shall apply to the department on forms prescribed by the department for approval of said technologies, equipment, or processes to ensure that established performance standards are met.     
       (1) Levels of microbial inactivation.                (A) All laboratory evidence submitted to the department for review shall be provided by a laboratory that meets the standards of either the NSF International, the American Association for Laboratory Accreditation, or other accrediting agencies or organizations as approved by the department.                 (B) All manufacturers of commercially-available alternate technologies, equipment, or processes designed and intended for the treatment of special waste from health care-related facilities shall provide specific laboratory evidence that demonstrates:                    (i) inactivation of representative samples of vegetative bacteria, mycobacteria, lipophilic/hydrophilic viruses, fungi, and parasites at a level of 6 log                       10                      reduction or greater, as determined by the department; and                     (ii) inactivation of Bacillus stearothermophilus endospores or Bacillus subtilis endospores at a level of 4 log                       10                      reduction or greater, as determined by the department.                   (C) One or more representative surrogate microorganisms from each microbial group shall be used in treatment efficacy evaluation. The department shall determine the appropriate microorganisms to serve as representative surrogate microorganisms.                 (D) The department shall prescribe those categories (types) and percent composition of special waste from health care-related facilities that present the most challenge to said treatment effectiveness under normal operating conditions of the equipment or process.                 (E) Protocols developed for efficacy testing shall incorporate, as applicable, recognized, standard procedures. The protocols shall be congruent with the treatment method under review. The department shall determine the specific pieces of information to be provided by the manufacturer to assure a thorough evaluation of the alternate treatment technology.        
       (2) Documentation requirements.                (A) The manufacturer of the alternate treatment technology, equipment, or process shall provide to the department the following information:                    (i) a detailed description of the treatment equipment, equipment specifications, operating instructions, and parameters of normal operation, and information detailing the intended use and typical site for which the equipment is designed;                     (ii) complete documentation that the alternate treatment technology, equipment, or process meets microbial inactivation criteria for all required representative microorganisms for all department-specified challenge waste load compositions, including a description of the test methods used, and, upon request, the original data from test procedures conducted by the manufacturer;                     (iii) documentation on available parametric controls, and, where technically feasible, evidence that demonstrates the efficacy relationship between biological indicator data and data derived from real-time parametric monitoring equipment;                     (iv) details relating to waste residues including their potential hazards/toxicities and their specific mode of disposal or recycling;                     (v) documentation providing occupational health assurance, and the means of providing required training in equipment operations;                     (vi) evidence of United States Environmental Protection Agency registration and Texas Department of Agriculture registration for those treatment processes that employ a chemical agent to inactivate microorganisms, or evidence of approval of the treatment process by a state other than Texas;                     (vii) documentation that user verification testing protocols are workable and valid; and                     (viii) documentation of approval of the alternate treatment process or technology in other state(s) utilizing performance standard review, if applicable.                   (B) Documentation must be submitted to the department on forms provided by the department.        
       (3) Alternate treatment technology approval conditions.                (A) The alternate treatment technology approval is contingent upon the following conditions:                    (i) Alternate treatment technology approval is granted only for the conditions specified in the manufacturer's instructions, equipment specifications, and operating procedures and conditions, including but not limited to:                        (I) treatment time(s);                         (II) temperature(s);                         (III) pressures;                         (IV) chemical concentration(s);                         (V) irradiation dose(s);                         (VI) feed rate(s); and                         (VII) waste load composition(s).                       (ii) Any significant revision on the part of the manufacturer to either the operating conditions of the equipment's existing process or technology, or the fundamental principles of the process itself, i.e., the equipment now utilizes a different technology in part or altogether, will require re-application for approval to the department.                   (B) Prior approval granted by a state other than Texas that utilizes a performance standards approach to review alternate treatment technologies shall be considered as a basis for approval by the department if the department is provided with a valid and current approval, license, or permit issued by such state and substantial evidence to indicate that the performance standards upon which the approval, license, or permit was issued are equal to or more stringent than the performance standards included in this section.                 (C) Facilities are not obligated to petition the department for approval for previously approved waste treatment technology they have currently on site, but the following items will apply should current equipment be replaced, regardless of reason:                    (i) if the new equipment reflects a previously approved technology and is operated in accordance with §1.133(b) of this title, then purchase and installation can proceed without further action on the part of the department or the purchaser; or                     (ii) if the new equipment represents an alternate treatment technology subject to prior approval by the department, based on performance standards as outlined in this section, then it is the purchaser's responsibility to ensure that the manufacturer has obtained such approval prior to purchase.          
       (4) Fees and annual listing.                (A) Initial application fee.                    (i) The department shall charge an initial application fee for the evaluation of an alternate treatment technology pursuant to this section in the amount of $4,000.                     (ii) The initial application fee must be paid in full before the department undertakes its evaluation of the manufacturer's alternate treatment technology.                   (B) Annual listing.                    (i) Alternate treatment technologies must be listed at the time of the manufacturer's first sale of the product in Texas and prior to the product's purchase by a health care-related facility or any other person.                     (ii) Failure by the manufacturer to maintain the listing after purchase does not preclude use of the alternate treatment technology, its transfer or re-sale, so long as compliance with §1.136(c) of this title (relating to Approved Methods of Treatment and Disposition) is achieved.                     (iii) The department shall maintain a list of those approved alternate treatment technologies, including manufacturer, product name, model number, or other appropriate identifying information. The list shall be made available and distributed upon request by contacting the department.          
     Source Note:        The provisions of this §1.135 adopted to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TeReg 9709