Title: Section 55-2.5 - Department approval of methods

Effective Date

11/17/2004

55-2.5 Department approval of methods. Department approval of methods.

(a) A laboratory shall obtain department approval prior to performing a laboratory-developed method, or other method not otherwise approved or given similar recognition as described in section 55-2.1(e) of this Subpart. The department may approve such a method, provided the laboratory submits data and other information as required supporting the technical merit of the method, and demonstrating that that the 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, 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, including: sample source(s), dates and times collected, and matrix; whether the sample was spiked, and, if so, the spiking procedure; the approved method used; and analytical results for both the approved method and the method submitted for approval;

(4) data from inter-laboratory comparisons, demonstrating the method’s reproducibility;

(5) demonstration of capability data; and

(6) any other information pertinent to the department’s determination of the method’s technical merit.

(b) Provided all other requirements of subdivision (a) above are met, the department may approve a method for which reproducibility has not been demonstrated by inter-laboratory comparisons if the 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 the laboratory which applied for such approval.

(c) In addition to the requirements of subdivisions (a) and (b) above, the department may require successful completion of on-site demonstration analysis on samples designed to challenge the procedure.

(d) The department shall respond to a laboratory’s request for method approval, notifying the laboratory of method approval, method approval contingent upon approval by the EPA, proposed denial of the request, or the need for further information.\

(e) If the department proposes to deny a request for method approval, it shall advise the laboratory of such 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 the laboratory submits, within thirty (30) calendar days of the date of such notice, a written request for reconsideration, including all documentation and rationale in support of such request. Within thirty (30) calendar days of the date the department receives a request for reconsideration, the department shall issue a final determination concerning the request for reconsideration.

(f) Notwithstanding the provisions of this Subpart, the department 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 lacking, the department shall notify the affected laboratory(ies) of its proposed determination that the method may not be performed under a New York State environmental laboratory certificate of approval, 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 the laboratory(ies) 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. Within thirty (30) calendar days of the date of department receives of a request for reconsideration, the department shall issue a final decision regarding the request for reconsideration.

(g) All information and data pertinent to method approval shall be documented, and be made available for department review upon on-site assessment or upon request for a minimum of two (2) years after the date of the method’s discontinuation.

Volume

VOLUME A-1 (Title 10)

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