N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 70-5.2

Current through Register Vol. 46, No. 50, December 11, 2024

Section 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 years, renewable every two years.

(2) A renewal application shall be filed no later than 180 calendar days prior to expiration of an existing approval.

(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.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 70-5.2