N.Y. Comp. Codes R. & Regs. tit. 9 § 130.15

Current through Register Vol. 46, No. 51, December 18, 2024

Section 130.15 - Approval of Laboratory-Developed Methods

(a) A cannabis laboratory shall obtain approval from the Office prior to performing a laboratory-developed method, or other method not otherwise approved or given similar recognition as described in this Part. The Office may approve such a method, provided a cannabis laboratory submits data and other information as required supporting the technical merit of the method, and demonstrating that method's precision and accuracy are equivalent or superior to that of an approved method. Such data and information shall include, but not be limited to:

(1) a description of the method, including analyte or group of analytes, sample type, working range, reagents and their preparation, equipment specifications, analytical procedures, precision, accuracy, related calculations, intended purpose and pertinent literature citations;

(2) the anticipated date of method implementation;

(3) comparative data, if of the same technology, including: sample types, dates and times collected, and product or form, whether the sample was spiked, and, if so, the spiking procedure, and spiking samples at different concentrations; the approved method used; and analytical results for both the approved method and the method submitted for approval;

(4) data from two (2) or more proficiency tests;

(5) demonstration of capability data;

(6) limit of detection data, if applicable; and

(7) any other information pertinent to the Office's determination of the method's technical merit.

(b) Provided all other requirements of subdivision (a) above are met, the Office may approve a method for which reproducibility has not been demonstrated by inter-laboratory comparisons if a cannabis laboratory demonstrates that its performance of the method is technically acceptable for the intended sample types and analytical purpose. Such approval shall be limited to a cannabis laboratory which applied for such approval.

(c) In addition to the requirements of subdivisions (a) and (b) above, the Office may conduct a laboratory regulatory audit.

(d) The Office shall respond to a cannabis laboratory's request for method approval, notifying a cannabis laboratory of method approval, proposed denial of the request by the Office, or the need for further information.

(e) The Office may propose to deny a request for method approval if a method does not meet the established requirements. A cannabis laboratory shall be advised of a proposed denial and the reasons for the denial. A proposed denial shall become final thirty (30) calendar days from the date of notice of proposed denial, unless a cannabis laboratory submits, prior to the date that is thirty (30) calendar days after the date of such notice, a written request for reconsideration, including all documentation and rationale in support of such request. The Office shall consider a request for reconsideration and shall issue a final determination concerning the request for reconsideration.

(f) Notwithstanding the provisions of this Part, the Office may conduct an independent review of any approved method to substantiate or refute its technical merit. If the method's technical merit is found to be unacceptable, the Office shall notify a cannabis laboratory of its proposed determination that the method may not be performed under a New York State cannabis laboratory's permit, giving the reasons for such determination. Such proposed determination shall become final thirty (30) calendar days from the date of the notice of proposed determination, unless a cannabis laboratory offering such method submits, within thirty (30) calendar days of the date of the notice, a written request for reconsideration, including all documentation and rationale in support of such request. The Office shall consider a request for reconsideration and shall issue a final determination concerning the request for reconsideration.

(g) All information and data pertinent to method approval shall be documented and be made available for Office review at the time of a laboratory regulatory audit or upon request for a minimum of five (5) years after the date of the method's discontinuation.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.15

Adopted New York State Register March 22, 2023/Volume XLV, Issue 12, eff. 3/22/2023