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10 CRR-NY 70-5.1NY-CRR

STATE COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK

TITLE 10. DEPARTMENT OF HEALTH

CHAPTER II. ADMINISTRATIVE RULES AND REGULATIONS

SUBCHAPTER I. ENVIRONMENTAL HEALTH

PART 70. REGULATED MEDICAL WASTE

SUBPART 70-5. APPROVAL OF ALTERNATIVE TREATMENT TECHNOLOGIES FOR USE IN NEW YORK STATE

10 CRR-NY 70-5.1

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 log₁₀ reduction in viable cell concentrations; Bacillus atrophaeus or Geobacillus stearothermophilus are used as a biological indicator, effective treatment shall be demonstrated a 4 log₁₀ 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.

10 CRR-NY 70-5.1

Current through August 15, 2021

End of Document

IMPORTANT NOTE REGARDING CONTENT CURRENCY: The "Current through" date indicated immediately above is the date of the most recently produced official NYCRR supplement covering this rule section. For later updates to this section, if any, please: consult editions of the NYS Register published after this date; or contact the NYS Department of State Division of Administrative Rules at [email protected]. See Help for additional information on the currency of this unofficial version of NYS Rules.