N.Y. Comp. Codes R. & Regs. tit. 9 § 130.12

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

Section 130.12 - Cannabis Technical Director Qualifications

(a)

(1) A cannabis laboratory shall appoint one or more technical directors, who shall be fulltime members of the laboratory's staff, and who shall exercise actual supervision of laboratory operations, including the reporting of results from testing samples, during normal business hours. The designation of a lead technical director shall be documented; and

(2) a technical director shall have the requisite credentials and experience for an area of analysis, such as microbiology, analytical chemistry, organic chemistry, metals, inorganic chemistry, and physical analysis, and shall supervise only the areas of testing for which they meet the qualifications required by this section.

(b) A technical director's responsibilities shall include, but not be limited to, development and implementation of a quality system as defined in this Part, including: monitoring standards of performance in quality control and quality assurance; monitoring the validity of analyses performed and data generated to ensure reliable data; ensuring that sufficient numbers of qualified personnel are employed to supervise and perform the work of the laboratory; and providing educational direction to laboratory staff.

(c) A technical director may not serve as a technical director for more than one cannabis laboratory without written authorization from the Office. Circumstances to be considered in the Office's decision to grant such authorization may include, but not be limited to, the extent to which the operating hours of the laboratories to be directed overlap, adequacy of supervision in a cannabis laboratory, and availability of cannabis laboratory services in the area served.

(d) A technical director who is absent from a cannabis laboratory for a period of time exceeding fifteen (15) consecutive calendar days shall designate another full-time technical director, or where none is available, another staff member who meets the qualifications of this Part, to assume the responsibilities of technical director temporarily. Whenever the term of such temporary designation exceeds thirty-five (35) consecutive calendar days, the Office shall be notified in writing.

(e) A technical director of a cannabis laboratory engaged in organic chemical analysis shall be an individual with:

(1) an earned doctoral or master's degree in the chemical, environmental, physical or biological sciences, or engineering, with twenty-four (24) college semester credit hours in chemistry, or more, and one (1) or more years of experience in analysis of representative organic analytes for which the laboratory is permitted or seeking a permit; or

(2) a bachelor's degree in the chemical, environmental, physical, or biological sciences, or engineering, with twenty-four (24) college semester credit hours, or more, in chemistry and two (2) or more years of experience in analysis of representative organic analytes for which the laboratory is permitted or seeking a permit.

(f) A technical director of a cannabis laboratory engaged in metals analysis shall be and individual with:

(1) an earned doctoral or master's degree in the chemical, environmental, physical or biological sciences, or engineering, with twenty-four (24) college semester credit hours, or more, in chemistry, and one (1) or more years of experience in analysis of representative metals analytes for which the laboratory is permitted or seeking a permit; or

(2) a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, with twenty-four (24) college semester credit hours, or more, in chemistry and two (2) or more years of experience in analysis of representative metals analytes for which the laboratory is permitted or seeking a permit.

(g) A technical director of a cannabis laboratory engaged in inorganic chemistry analysis, other than metals analysis, and physical chemistry analysis, among other analysis, shall be a person with an associate's degree in the chemical, physical, biological or environmental sciences, or two (2) years of equivalent and successful college education, with sixteen (16) college semester credit hours, or more, in chemistry. In addition, such a person shall have two (2) or more years of experience performing such representative inorganic and physical chemistry analysis.

(h) A technical director of a cannabis laboratory engaged in microbiological and/or biological testing shall be an individual with:

(1) an earned doctoral degree or master's degree in the chemical, environmental, physical or biological sciences, or engineering, with sixteen (16) college semester credit hours, or more, in the biological sciences, including, for microbiological testing, at least once course having microbiology as a major component, and one (1) or more years of experience in analysis of representative microbiological analytes for which the laboratory is permitted or seeking a permit; or

(2) a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least sixteen (16) college semester credit hours, or more, in the biological sciences, including, for microbiological testing, at least one course having microbiology as a major component, and two (2) or more years of experience in analysis of representative microbiological analytes for which the laboratory is permitted or seeking a permit.

(i) An individual who meets the experience requirements but not the educational and/or credential requirements of this Part, and is functioning in a technical director's capacity as subject to this section, and is functioning in a technical director's capacity on the date a cannabis laboratory becomes subject to these regulations, shall qualify as technical director of that cannabis laboratory, or any other cannabis laboratory permitted by the Office and performing similar testing, provided such individual has been technical director in that cannabis laboratory for the previous twelve (12) consecutive months, or more, will oversee only those areas of testing for which they were a technical director for at the least previous twelve (12) consecutive months, and can demonstrate the ability to comply with the proficiency test and quality system requirements of this Part. An individual who is admitted as a technical director under these conditions, and leaves a cannabis laboratory, will be eligible for hire as a technical director for the same area of testing in another permitted cannabis laboratory.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.12

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