N.Y. Comp. Codes R. & Regs. tit. 9 § 130.2

Current through Register Vol. 46, No. 43, October 23, 2024

Section 130.2 - Cannabis Laboratory Permit Application

(a) No person shall be a cannabis laboratory authorized to test medical cannabis and adult- use cannabis and issue laboratory test reports required by the Cannabis Law unless they have been granted a cannabis laboratory permit. A laboratory certified by the New York State Department of Health to conduct medical cannabis testing shall be deemed a provisional permittee and must comply with this Part.

(b)

(1) An application for a cannabis laboratory permit shall be submitted to the Office in a manner and format determined by the Board. The application shall be signed by technical directors of a cannabis laboratory, and the following individuals:

(i) by the applicant (if an individual);

(ii) by a managing member (if a limited liability company);

(iii) by an officer (if a corporation),

(iv) by all partners (if a partnership); or

(v) by an officer, director or trustee if an institution, trust, estate, or any other legal entity.

(2) At the time of application for a cannabis laboratory permit, the Board may require information regarding a cannabis laboratory, including, but not limited to:

(i) proof of ISO/IEC 17025 accreditation;

(ii) ownership, true parties of interest, financiers, organization structure;

(iii) quality control systems;

(iv) proficiency testing program;

(v) the premises;

(vi) qualification of personnel;

(vii) training programs;

(viii) consumables including but not limited to reagents and standard reference materials;

(ix) laboratory equipment;

(x) method of reporting results; and

(xi) any other information as requested by the Office.

(3) An application for a cannabis laboratory permit under this Part shall be accompanied by a non-refundable application fee in the amount of $1,000.00. Prior to issuance or renewal of a permit, an application or renewal application fee of $1,000, and permit fee shall be paid, unless otherwise expressly authorized by the Board pursuant to this Part.

(4) For an analyte or group of analytes which the Office requires testing, an application for a cannabis laboratory permit shall specify an analyte or group of analytes that a cannabis laboratory is seeking approval for, the cannabis product or medical cannabis and any other intermediates or forms to be analyzed, and the approved methods to be employed for an analyte or group of analytes in cannabis product or medical cannabis, and any other intermediates or forms.

(c) Upon receipt of such application, the Office shall review a cannabis laboratory's performance on proficiency tests and proficiency test samples, quality system documentation, technical director credentials, performance in laboratory regulatory audit, if applicable, and any additional materials and/or information requested by the Office. The Office shall make a preliminary determination whether the applicant qualifies for a cannabis laboratory permit, the analyte or group of analytes for which the applicant has applied, and the application and permit fee to be paid. The Board will issue the final determination on whether or not to approve or deny a cannabis laboratory permit.

(d) For purposes of the application and permit process, testing facilities housed in separate buildings shall be considered separate cannabis laboratories and require separate cannabis laboratory permits, unless such facilities obtain a written waiver from the Office. The Office may provide a waiver if the Office determines that:

(1) effective supervision of the operation of all such facilities can be exercised by the same technical director;

(2) the facilities can share the same quality manual, standard operating procedures and record and reporting templates; however, the analytical, record keeping, and reporting results are not duplicative between the facilities; and

(3) the facilities are owned by the same legal entity or same individual.

(e) A cannabis laboratory applicant may withdraw an application at any time prior to the issuance or denial of a permit provided that:

(1) a notice to withdraw an application is submitted to the Office in writing, dated, and signed by the applicant.

(f) A cannabis laboratory applicant may reapply at any time following the withdrawal of an application and will be required to submit a new application and application fee prior to any deadline for such application.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 130.2

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