OAR 333-064-0100
Marijuana Item Sampling Procedures and Testing

(1) For purposes of this rule the definitions in OAR 333-007-0310 (Definitions) apply unless the context indicates otherwise.
(2) Sampling.
(a) A laboratory must have and follow marijuana item sampling policies and procedures, accredited by ORELAP, that:
(A) Ensure sampling will result in a sample that is representative of the batch being sampled.
(B) Require sampling and laboratory personnel to document and collect any information necessary for compliance with these rules, OAR chapter 333, division 7, and any applicable TNI standards.
(C) Require chain of custody procedures consistent with TNI EL Standard V1M2 5.7 and 5.8.
(D) Are appropriate to the matrix being sampled.
(E) Are consistent with OAR 333-007-0360 (Sampling and Sample Size Requirements for Compliance Testing) and 333-007-0370 (Sampling Personnel Requirements; Sampling Recordkeeping) and the following ORELAP sampling protocols approved by the accrediting body, incorporated by reference:
(i) Usable Marijuana: ORELAP-SOP-001 Rev 4.0; and
(ii) Concentrates, Extracts, and Products: ORELAP-SOP-002 Rev 4.1.
(F) Ensure that only the finished cannabinoid concentrate, extract or product is sampled if testing on the finished cannabinoid concentrate, extract or product is required under OAR 333-007-0330 (Compliance Testing Requirements for Cannabinoid Concentrates and Extracts) and OAR 333-007-0340 (Compliance Testing Requirements for Cannabinoid Products).
(G) Contain training and education requirements for sampling personnel.
(b) Sampling policies and procedures must be accredited by ORELAP prior to any marijuana samples being taken.
(c) Laboratory personnel that perform sampling must:
(A) Comply with the laboratory’s accredited sampling policies and procedures.
(B) After taking samples:
(i) Document the samples in accordance with subsection (2)(e) of this rule; and
(ii) If sampling for a licensee or a registrant required to comply with CTS tracking under ORS 475B.895 (Use of Oregon Liquor Control Commission tracking system), record the sampling and transfer information in the Commission’s seed to sale system, as required by the Authority and the Commission; and
(C) Take care while sampling to avoid contamination of the non-sampled material. Sample containers must be free of analytes of interest and appropriate for the analyses requested.
(D) Take sample increments that are representative of the batch being sampled.
(d) A sufficient sample size must be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests.
(e) A laboratory must comply with any recording requirements for samples and sample increments in the accredited policies and procedures and at a minimum:
(A) Record the location of each sample and sample increment taken.
(B) Assign a field identification number for each sample, sample increment and field duplicate that have an unequivocal link to the laboratory analysis identification.
(C) Assign a unique identification number for the test batch in accordance with OAR 333-007-0370 (Sampling Personnel Requirements; Sampling Recordkeeping) and TNI EL standard requirements.
(D) Have a documented system for uniquely identifying the samples to be tested to ensure there can be no confusion regarding the identity of such samples at any time. This system must include identification for all samples, sample increments, preservations, sample containers, tests, and subsequent extracts or digestates.
(E) Place the laboratory identification code as a durable mark on each sample container.
(F) Enter a unique identification number into the laboratory records. This number must be the link that associates the sample with related laboratory activities such as sample preparation. In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the unique identification number may be the same as the field identification code.
(f) Combining sample increments.
(A) Sample increments collected from the same batch of usable marijuana must be combined into a single sample by a laboratory prior to testing. Sample increments from a batch of a cannabinoid concentrate, extract or product may be combined into a single sample by a laboratory prior to testing if the cannabinoid concentrate, extract or product has a certified control study. Prior to any testing, the combined sample must undergo the laboratory’s homogenization process. If the homogenization process would invalidate the analysis for a required test, the laboratory must utilize a subsampling procedure to withdraw a portion of the sample prior to homogenization for the required test. Testing that would be invalidated by the homogenization process includes but is not limited to, cryogenic sterilization of the sample prior to microbiological analysis.
(B) Sample increments and samples collected from different batches may not be combined, except as permitted by OAR 333-007-0360 (Sampling and Sample Size Requirements for Compliance Testing).
(C) Field duplicates may not be combined with the primary samples.
(3) THC and CBD testing validity. When testing a sample for THC and CBD a laboratory must comply with additional method validation as follows:
(a) Run a laboratory control standard in accordance with TNI standards requirements within acceptance criteria of 70 percent to 130 percent recovery.
(b) Analyze field duplicates of samples within precision control limits of plus or minus 20 percent RPD, if field duplicates are required.
(4) Calculating total THC and total CBD.
(a) Total THC must be calculated as follows, where M is the mass or mass fraction of delta-9 THC or delta-9 THCA:
(b) Total CBD must be calculated as follows, where M is the mass or mass fraction of CBD and CBDA:
(c) Each test report must include the total THC and total CBD.
(5) Report total THC and total CBD for useable marijuana as Dry Weight. A laboratory must analyze the sample as received and report total THC and Total CBD content by dry weight calculated as follows:
(6) Calculating RPD and RSD.
(a) A laboratory must use the following calculation for determining RPD:
(b) A laboratory must use the following calculation for determining RSD:
(c) For purposes of this section:
(A) S = standard deviation.
(B) n = total number of values.
(C) xi = each individual value used to calculate mean.
(D) x = mean of n values.
(d) For calculating both RPD and RSD if any results are less than the LOQ the absolute value of the LOQ is used in the equation.
(e) The laboratory shall not substitute the LOQ for individual components of a totaled result, such as total THC or total Hexanes, in the calculation of the totaled result for the purpose of calculating RPD or RSD.
(7) Tentative Identification of Compounds (TIC).
(a) If a laboratory is using a gas chromatography mass spectrometry instrument for analysis when testing cannabinoid concentrates or extracts for solvents and determines that a sample may contain compounds that are not included in the list of analytes the laboratory is testing for the laboratory must attempt to achieve tentative identification.
(b) Tentative identification is achieved by searching NIST 2014 or an equivalent database (>250,000 compounds).
(c) A laboratory shall report to the licensee or registrant and the Authority or the Commission, depending on which agency has jurisdiction, up to five tentatively identified compounds (TICS) that have the greatest apparent concentration.
(d) Match scores for background subtracted or deconvoluted spectra should exceed 90 percent compared to library spectrum.
(A) The top five matches over 90 percent must be reported by the lab
(B) TIC quantitation is estimated by comparing analyte area to the closest internal standard area and assuming a response factor (RF) =1.
(8) A laboratory must provide:
(a) Any pesticide test result to the Department of Agriculture upon that agency’s request.
(b) A sample or a portion of a sample to the Department of Agriculture upon that agency’s request, document the chain of custody from the laboratory to the Department, and document that the sample or portion of the sample was provided to the Department in the Commission’s seed to sale tracking system.
(9) A laboratory performing tests for a licensee or a registrant required to use CTS under ORS 475B.895 (Use of Oregon Liquor Control Commission tracking system) must enter any information required by the Commission or the Authority in CTS.
(10) A laboratory performing tests for a registrant must comply with the documentation requirements in OAR 333-007-0370 (Sampling Personnel Requirements; Sampling Recordkeeping) and must maintain the documentation required in these rules for at least three years and provide that information to the Authority upon request.
(11) The Authority may, in its discretion, deviate from TNI Standards in order to comply with OAR 333-007-0400 (Standards for Pesticides Compliance Testing) to 333-007-0500 (Quality Control and Research and Development Testing) and these rules based on the state’s needs.
(12) A laboratory must be able to demonstrate that its LOQ is:
(a) Below any action level established in OAR 333-007-0400 (Standards for Pesticides Compliance Testing) and 333-007-0410 (Standards for Solvents Compliance Testing), Exhibit A, Tables 3 and 4; and
(b) For THC concentration below 0.3 percent.
(13) Non-compliance testing. A laboratory that conducts a quality control or research and development test for a registrant or licensee may use methods not approved by the Authority but the laboratory may not identify those test results as accredited results.
[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Source: Rule 333-064-0100 — Marijuana Item Sampling Procedures and Testing, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-064-0100.

Last Updated

Jun. 8, 2021

Rule 333-064-0100’s source at or​.us