N.Y. Comp. Codes R. & Regs. tit. 9 § 130.1

Current through Register Vol. 46, No. 25, June 18, 2024

Section 130.1 - Definitions

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.

(j)Laboratory regulatory audit means an on-site or virtual assessment or audit conducted by the Office, or by a state regulatory program recognized by the Office pursuant to this Part.

(k)Lead technical director means a technical director or manager (1) that a cannabis laboratory designates to be directly responsible for overall administration of the technical and scientific operation of a cannabis laboratory, including the supervision of other technical directors or managers, and (2) whose name appears on the permit issued under this Part and on the application, proficiency tests and any laboratory regulatory audit materials submitted by a laboratory to the Office in connection with an application for a permit under this Part.

(l)Laboratory technician means a laboratory technician or analyst who is responsible for culturing, extracting or testing cannabis samples using analytical instrumentation including, but not limited to solid phase extraction, gas chromatography, liquid chromatography, inductively coupled plasma ' mass spectrometry, and polymerase chain reaction.

(m)Permit year shall mean the approval year which is a period during which a cannabis laboratory is authorized to operate, commencing on April 1 and ending on March 31, unless otherwise renewed or extended as set forth in this Part.

(n)Phytocannabinoid refers to any of the chemical compounds, excluding terpenes or any other compounds set forth by the Office, that are the active principles of cannabis sativa, including but not limited to tetrahydrocannabinol (THC) and cannabidiol (CBD), and does not include synthetic cannabinoids as that term is defined in subdivision (g) of schedule I of section thirty-three hundred six of the public health law.

(o)Proficiency test (PT) means a test that requires a laboratory to produce analytical results within acceptable limits on an analyte or group of analytes of which the concentration and identity is unknown to the laboratory or its employees but known to a proficiency test provider.

(p)Proficiency Test Provider (PTP) means an entity with an ISO/IEC 17043 accreditation for cannabis testing and is independent of a laboratory for which it provides a proficiency test. A proficiency testing provider needs to be independent of a cannabis testing laboratory whether it provides proficiency testing to the laboratory or not.

(q)Proficiency Test Provider Accreditor (PTPA) means an entity independent of the laboratory and proficiency test provider (PTP) that accredits the PTP to ISO/IEC 17043 accreditation.

(r)Proficiency test sample (PT sample) means a sample that a PTP provides to a laboratory to conduct a proficiency test.

(s)Quality assurance officer means a quality assurance director, quality assurance manager or any other individual who is responsible for an integrated system of activities involving quality control, quality assurance, and quality improvements to ensure that a service meets defined standards of quality with a stated level of confidence.

(t)Quality system means a structured laboratory management system that meets the standards for a quality system as determined by the Office.

(u)State reference laboratory means a cannabis laboratory with which the Office contracts, or a laboratory operated by the NYS Department of Health, whose duties include, but are not limited to, reviews or retests of samples and investigational support as requested by the Office.

(v)Technical director means an individual responsible for the technical and scientific operation of a cannabis laboratory, and who meets the minimum qualifications in this Part. If a cannabis laboratory employs more than one technical director, a cannabis laboratory shall designate one technical director as the lead technical director.

(w)True party of interest means a person that has 10% or more of a direct or indirect interest in a cannabis laboratory or a cannabis laboratory sampling firm, excluding passive investors, who are those who have less than a 5% direct or indirect interest of a licensee with an aggregate ownership interest whose shares are publicly traded, as set forth by the Office in applicable regulations under this Title or under applicable guidance.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.1

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