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