SubPart 70-5 - Approval of Alternative Treatment Technologies for Use in New York State

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-5.1 - Treatment technology approval

70-5.1 Treatment technology approval. (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) submit an application on forms prescribed by the Commissioner of Health;

(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) provide documentation that any chemical used in system to treat regulated medical waste has been registered with the federal Environmental Protection Agency;

(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: (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 (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) 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.

(b) Whenever Mycobacterium species is used as a biological indicator, effective treatment shall be demonstrated by a 6 log 10 reduction in viable cell concentrations;

Bacillus

atrophaeus

or

Geobacillus

stearothermophilus

are used as a biological indicator, effective treatment shall be demonstrated a 4 log 10 reduction in viable spores concentration. No alternative treatment system that fails to attain such reductions or fails to demonstrate that the waste has been treated shall be used to treat regulated medical waste.

(c) The Department may require that the system undergo supplemental efficacy testing using organisms or agents other than those identified in subdivision (b) of this section, and may require the manufacturer to demonstrate that the technology meets manufacturer’s claims for effective treatment of non-typical bioloads or materials, for example, new and emerging pathogens or pathological waste.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete

Section 70-5.2 - Limitations and voiding of approval

70-5.2 Limitations and voiding of approval. (a)(1) Approval shall be limited to the specific system model or version authorized by the Commissioner of Health, and shall be valid for a period not to exceed two (2) years, renewable every two (2) years;

(2) a renewal application shall be filed no later than one hundred and eighty (180) calendar days prior to expiration of an existing approval; and

(3) each renewal application shall identify all installations of approved technology(ies) for the applicant manufacturer in New York State.

(b) Approval shall be limited to the waste materials and components, operating parameters and conditions, including the introduction of other materials into a load, specified in the efficacy testing data submitted to and approved by the Department.

(c) Approval shall become void upon any change to the system by the manufacturer that may adversely affect the system’s efficacy, as determined by the Department. Such change shall include, but not be limited to, claims that the technology is able to render harmless, dispose of, or otherwise handle wastes and materials, concurrent with regulated medical waste loads or in different loads, other than the type(s) of regulated medical waste for which the technology was approved.

(d) The Department may require the submission of additional information and specific data as may be pertinent to demonstrating safety and efficacy of the alternative technology.

Effective Date: 
Wednesday, March 15, 2006
Doc Status: 
Complete