(a) No alternative regulated medical waste treatment system shall be used in New York State unless the Commissioner of Health has approved the system's technology pursuant to this Subpart. The system manufacturer, as applicant for technology approval, shall:

1. (1) submit an application on forms prescribed by the Commissioner of Health;
2. (2) demonstrate that the system's operation does not pose a threat to public health or safety, including documentation that any chemical used in the system has been registered and approved by the New York State Department of Environmental Conservation for use in New York State;
3. (3) provide documentation that any chemical used in system to treat regulated medical waste has been registered with the Federal Environmental Protection Agency;

4. (4) establish the system's operating parameters through efficacy testing, and demonstrate that the system effectively treats regulated medical waste. Unless precluded by system design:

   1. (i) efficacy testing shall be conducted on an actual full-scale working model of the system, rather than a simulation, or other substitution in scale or in kind; and
   2. (ii) such testing shall employ surrogate test loads, varying in organic to non-organic and solid to liquid compositions. Such surrogate test loads shall include mycobacterium species and/or other appropriate indicators as determined by the department, that has been strategically placed throughout the test loads; and
5. (5) agree to provide all facilities in New York State that use the alternative treatment system with a copy of the department's technology approval letter, and any appendices or amendments thereto for the period in which the system is in use in New York State.