N.Y. Comp. Codes R. & Regs. tit. 9 § 114.10

Current through Register Vol. 46, No. 36, September 4, 2024

Section 114.10 - Laboratory testing requirements for cannabinoid hemp

(a) For purposes of this Section, the following terms shall have the following meanings:

(1) "Accreditation body" means an impartial non-profit organization that operates in conformance with the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing.

(2) "Scope of accreditation" means a document issued by an accreditation body that attests to the laboratory's competence to carry out specific testing and analysis.

(3) "Testing laboratory" means an independent, third-party laboratory, contracted by a cannabinoid hemp processor to test cannabinoid hemp products.

(b) To be recognized as a testing laboratory for purposes of testing cannabinoid hemp products as required by this Part, a laboratory must either be approved to test cannabis pursuant to Part 130 of this Title, article 6 of the Cannabis Law, or meet all of the following minimum requirements:

(1) maintain ISO/IEC 17025 accreditation for the premises and for the testing of one or more of the analytes determined by the office, pursuant to section 130.22(d) of this Title.

(2) maintain a valid scope of accreditation, issued by an accreditation body, that attests to the laboratory's competence to perform testing of one or more analytes in subdivision (b)(1) of this section.

(3) maintain method validation reports for all testing performed; and

(4) maintain standard operating procedures for the sampling of cannabinoid hemp products.

(c) Cannabinoid hemp processors shall retain, and make available to the office upon request, all records associated with their testing laboratory's ISO/IEC 17025 accreditation, scope of accreditation, method validation reports and standard operating procedures for the sampling of cannabinoid hemp products, as required by this section.

(d) Cannabinoid hemp products shall be considered adulterated and shall not be sold within New York State, if contaminants are detected at levels greater than provided for by the office in this Part or issued in further guidance.

(e) The office shall have the ability to impose additional testing requirements including but not limited to, testing for additional analytes, setting stricter contaminant limits and mandating the use of specific sampling methodologies per lot or batch manufactured.

(f) Testing limits. Pursuant to section 130.22(d) of this Title, the office shall make available a list of required analytes, their acceptable limits and approved testing methods on the office's website and in any other manner as determined by the Board.

(g) Cannabinoid Limits. The total [DELTA] 9-Tetrahydrocannabinol concentration for cannabinoid hemp products shall not exceed three-tenths of a percent (0.3%). If a cannabinoid hemp product fails, the processor may elect to re-formulate the failing batch to reduce the total [DELTA] 9-Tetrahydrocannabinol of the batch to not more than three-tenths of a percent (0.3%) total [DELTA] 9-Tetrahydrocannabinol. If the re-formulated batch still exceeds the three-tenths of a percent (0.3%) total [DELTA] 9-Tetrahydrocannabinol the processor shall destroy the batch in compliance with subdivision (d) of section 114.7 of this Part.

(h) If a cannabinoid hemp product is found to contain levels of any pathogen, toxicant, residual solvent, metal, or pesticide not enumerated in this section or by New York State law, then the product shall not be sold in New York State.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 114.10

Adopted New York State Register November 24, 2021/Volume XLIII, Issue 47, eff. 11/24/2021

Amended New York State Register October 5, 2022/Volume XLIV, Issue 40, eff. 10/5/2022

Amended New York State Register December 13, 2023/Volume XLV, Issue 50, eff. 12/13/2023