New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 130 - Cannabis Laboratories › Section 130.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For purposes of this Part, the following terms shall have the
				  following meanings:
(a)
Analyte
means a contaminant, chemical and/or physical
				property, element, compound, organism, or group of any of the foregoing, the
				existence and amount of which a laboratory testing facility tests for or
				identifies in a sample.
(b)
Analyte withdrawal
means a cannabis laboratory's request to
				remove approval for an analyte or group of analytes, in total or in
				part.
(c)
Approved
				method
means an analytical method, including sample preparation, of
				proven reliability which has been approved or recognized by this Part, any New
				York State agency, or other regulatory program, for the specific purpose for
				which the method is to be used.
(d)
Cannabis laboratory
means a laboratory testing facility as
				defined in the Cannabis Law.
(e)
Cannabis laboratory permit
means a permit issued under this
				Part to a cannabis laboratory.
(f)
Cannabis product batch
means a uniquely defined quantity of
				medical cannabis or cannabis product; including pre-roll, that is uniform in
				processing, manufacture, and packaging within a concurrent time
				frame.
(g)
Certificate of
				analysis
means a certified report from a cannabis laboratory meeting
				the requirements of this Part.
(h)
Data integrity training
means training related to the
				following topics, among others: organizational mission and its relationship to
				the critical need for honesty and full disclosure in all sampling;
				transportation and analytical reporting; how and when to report data integrity
				issues; record keeping; and breaches of ethical behavior, including but not
				limited to, improper data manipulations, adjustments of instrument time-clocks,
				dry-labbing, and changes in: concentrations of standards, date and time of
				sampling, transport, and analysis.
(i)
Gross Annual Receipts
means:
(1) for an independent cannabis
				laboratory or cannabis laboratory operated within a facility which can
				segregate its laboratory income from total facility income, gross annual
				receipts means the total income of a cannabis laboratory from all sources for
				all laboratory tests performed pursuant to its permit under this Part, less any
				amounts paid to reference laboratories for such tests which are
				referred;
(2) for a cannabis
				laboratory operated by a facility which is reimbursed by third-party payors for
				laboratory services as part of an all-inclusive facility per diem rate and
				which cannot segregate laboratory income from total facility income, gross
				annual receipts means (x) the total annual cost of a cannabis laboratory
				multiplied by a fraction, the numerator of which is the gross revenue of the
				facility and the denominator of which is the gross cost of the operating
				facility, less (y) any amounts paid to reference laboratories for such tests
				which are referred; or
(3) for any
				other cannabis laboratory unable to segregate its annual income from tests
				performed pursuant to its permit under this Part, gross annual receipts means
				the amount a cannabis laboratory would have received had it billed the
				prevailing rate for such services. A cannabis laboratory must demonstrate to
				the Office its inability to segregate its annual income and obtain prior Office
				approval to use the approved method set forth in subdivision (c) of this
				section.